Report scope. This 2026 Drug Asset Due Diligence Report evaluates MK-2206 as a potential licensing, partnership, acquisition, or option asset. The review separates verified evidence from open diligence questions across clinical development, intellectual property, market positioning, and transaction precedent.
Executive recommendation: CONDITIONAL GO
MK-2206 is a Small molecule drug associated with Akt-1 and a global highest development stage of Phase 2. The lead disclosed indication is Recurrent Prostate Carcinoma. The current evidence supports a CONDITIONAL GO posture, subject to confirmation of study-level data, ownership, patent coverage, manufacturing readiness, and regional rights.
Decision memo
- Asset: MK-2206
- Target: Akt-1
- Lead indication: Recurrent Prostate Carcinoma
- Highest phase: Phase 2
- Matched trials: 45
- Matched result records: 58
- Matched asset deals: 0
Use PatSnap Life Sciences MCP servers to validate the MK-2206 diligence evidence.
1. Asset identity and development status
The first diligence task is entity resolution. Teams should reconcile development codes, nonproprietary names, salts, formulations, combinations, sponsors, and predecessor owners before relying on portfolio counts. For MK-2206, the MCP profile identifies Akt-1 as the primary target context and Recurrent Prostate Carcinoma as the lead indication. Global phase labels are useful orientation points, but investment decisions require country- and indication-level status verification.
Confirm the exact molecule, formulation, route, dose, biomarker definition, and current sponsor. Review discontinuations separately from active development so that an historical high phase is not mistaken for a live program.
Use PatSnap Life Sciences MCP servers to validate the MK-2206 diligence evidence.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT01859182 | Phase 2 | Withdrawn | Not disclosed | Not disclosed |
| NCT01802320 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01783171 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT01776008 | Phase 2 | Terminated | Not disclosed | Not disclosed |
| NCT01705340 | Phase 1 | Terminated | Not disclosed | Not disclosed |
| NCT01658943 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01604772 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01519427 | Phase 2 | Terminated | Not disclosed | Not disclosed |
| NCT01481129 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01480154 | Phase 1 | Active, not recruiting | Not disclosed | Not disclosed |
| NCT01466868 | Phase 2 | Terminated | Not disclosed | Not disclosed |
| NCT01425879 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01369849 | Phase 1/2 | Completed | Not disclosed | Not disclosed |
| NCT01349933 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01344031 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT01333475 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01319539 | Phase 2 | Terminated | Not disclosed | Not disclosed |
| NCT01307631 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01295632 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT01294306 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01283035 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01281163 | Phase 1 | Terminated | Not disclosed | Not disclosed |
| NCT01277757 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01263145 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT01260701 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01258998 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01253447 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01251861 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01249105 | Phase 2 | Withdrawn | Not disclosed | Not disclosed |
| NCT01248247 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01245205 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT01243762 | Phase 1 | Terminated | Not disclosed | Not disclosed |
| NCT01240941 | Phase 2 | Withdrawn | Not disclosed | Not disclosed |
| NCT01239342 | Phase 2 | Terminated | Not disclosed | Not disclosed |
| NCT01239355 | Phase 2 | Terminated | Not disclosed | Not disclosed |
| NCT01235897 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT01231919 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT01186705 | Phase 2 | Terminated | Not disclosed | Not disclosed |
| NCT01169649 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT01147211 | Phase 1 | Unknown status | Not disclosed | Not disclosed |
| NCT01071018 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT01021748 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT00963547 | Phase 1 | Terminated | Not disclosed | Not disclosed |
| NCT00848718 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT00670488 | Phase 1 | Completed | Not disclosed | Not disclosed |
The clinical program should be audited for randomization, comparator relevance, dose selection, endpoint hierarchy, multiplicity, analysis population, geographic mix, and readout timing. Early-stage programs require attention to pharmacokinetics, pharmacodynamics, adverse events, dose-limiting toxicities, and the rationale for the expansion dose.
Use PatSnap Life Sciences MCP servers to validate the MK-2206 diligence evidence.
3. Clinical readouts: what is known
Phase II Randomized Study of MK‐2206 and Bicalutamide in Prostate Cancer Patients With Rising PSA After Primary Therapy (ECOG‐ACRIN E2809)
Study: NCT01251861 (E2809, Pubmed | Prostate). Phase: Phase 2. Enrollment: 108. Published: 2026-01-29.
PD(at EP1) = 19.0 % | PD(at EP1) = 18.0 %
A phase 2 study of MK‐2206 in patients with incurable adenoid cystic carcinoma (Alliance A091104)
Study: NCT01604772 (Alliance A091104, Pubmed | Cancer). Phase: Phase 2. Enrollment: 16. Published: 2024-03-01.
Adverse Event: decreased lymphocyte count = 13%
Pilot Trial of Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies
Study: NCT01306045 (CTgov). Phase: Phase 2. Enrollment: 647. Published: 2023-04-11.
Tumor protein p53 (TP53) = 28.5 % | Tumor protein p53 (TP53) = 44.2 %
The ImPrint immune signature to identify patients with high-risk early breast cancer who may benefit from PD1 checkpoint inhibition in I-SPY2.
Study: NCT01042379 (I-SPY2, ASCO2022). Phase: Phase 2. Enrollment: 69. Published: 2022-06-02.
ImPrint signature = A signature of 53 genes, named ImPrint, was identified with overall sensitivity and specificity > 90% and > 80% for predicting pCR to pembrolizumab in all patients. Sensitivity and specificity in TN were > 95% and ≥70%, and in HR+HER2- > 80% and > 85%, respectively. The Positive Predictive Value (PPV) is 77% for the HR+HER2- subgroup. | ImPrint signature = A signature of 53 genes, named ImPrint, was identified with overall sensitivity and specificity > 90% and > 80% for predicting pCR to pembrolizumab in all patients. Sensitivity and specificity in TN were > 95% and ≥70%, and in HR+HER2- > 80% and > 85%, respectively. The Positive Predictive Value (PPV) is 77% for the HR+HER2- subgroup.
BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
Study: NCT01248247 (BATTLE-2, CTgov). Phase: Phase 2. Enrollment: 334. Published: 2022-01-12.
PR = 0 Pts | PR = 0 Pts
A Phase I Study of Dinaciclib in Combination With MK-2206 in Patients With Advanced Pancreatic Cancer
Study: NCT01783171 (Pubmed | Clin Transl Sci). Phase: Phase 1. Enrollment: 39. Published: 2020-11-01.
MTD = dinaciclib 9 mg/m2 and MK-2206 135 mg
Phase II, 2-stage, 2-arm, PIK3CA mutation stratified trial of MK-2206 in recurrent endometrial cancer
Study: NCT01307631 (Pubmed | Int J Cancer). Phase: Phase 2. Enrollment: 36. Published: 2020-07-15.
ORR(mutant) = 1 Pts
Androgen Receptor Modulation Phase II, Randomized Study of MK-2206 - Bicalutamide Combination in Patients With Rising PSA at High-Risk of Progression After Primary Therapy
Study: NCT01251861 (E2809, CTgov). Phase: Phase 2. Enrollment: 108. Published: 2019-12-05.
The Proportion of Patients With Undetectable PSA Level (< 0.2 ng/mL) at 44 Weeks = 0.093 % (80%CI, 0.046 - 0.165) | The Proportion of Patients With Undetectable PSA Level (< 0.2 ng/mL) at 44 Weeks = 0.148 % (80%CI, 0.088 - 0.23)
Phase II trial of AKT inhibitor MK-2206 in patients with advanced breast cancer who have tumors with PIK3CA or AKT mutations, and/or PTEN loss/PTEN mutation
Study: NCT01277757 (Pubmed | Breast Cancer Res). Phase: Phase 2. Enrollment: 27. Published: 2019-07-05.
ORR = 5.6 % | ORR = 0 %
Abstract P2-03-01: Akt inhibition associated with change in immunophenotype of tumor microenvironment (TME) in breast cancer (BC)
Study: NCT01319539 (P2-03-01, SABCS2019). Phase: Phase 2. Enrollment: Not disclosed. Published: 2019-02-15.
CTL density = 87 %
A Phase I Investigation of the Combination of MK-2206, Trastuzumab and Lapatinib in HER2+ Solid Tumors
Study: NCT00963547 (MK-2206-015 | 2206-015, CTgov). Phase: Phase 1. Enrollment: 33. Published: 2018-10-31.
Number of Participants Experiencing ≥1 Adverse Event = 3 Pts | Number of Participants Experiencing ≥1 Adverse Event = 11 Pts
A Phase I Study of Oral MK-2206 in Combination With Oral AZD6244 in Patients With Locally Advanced or Metastatic Solid Tumors
Study: NCT01021748 (2206-010, CTgov). Phase: Phase 1. Enrollment: 63. Published: 2018-08-07.
Number of Participants With a Dose-limiting Toxicity (DLT) = 0 Pts | Number of Participants With a Dose-limiting Toxicity (DLT) = 2 Pts
Association of Akt inhibition with change in immunophenotype of tumor microenvironment (TME) in breast cancer (BC).
Study: NCT01319539 (ASCO2018). Phase: Phase 2. Enrollment: Not disclosed. Published: 2018-06-01.
CD8 lymphocytes = 87 %
A Phase II Trial of Neoadjuvant MK-2206 in Combination With Either Anastrozole if Postmenopausal or Anastrozole and Goserelin if Premenopausal in Women With Clinical Stage 2 or 3 PIK3CA Mutant Estrogen Receptor Positive and HER2 Negative Invasive Breast Cancer
Study: NCT01776008 (CTgov). Phase: Phase 2. Enrollment: 16. Published: 2018-05-08.
pCR = 0 Pts
Phase I Parallel Arm Study of MK-0646 (Dalotuzumab) + MK-2206, Dalotuzumab + MK-0752, and Dalotuzumab + MK-8669 (Ridaforolimus) Doublets (MK-MK Doublets) in Patients With Advanced Cancer
Study: NCT01243762 (0646-027, CTgov). Phase: Phase 1. Enrollment: 47. Published: 2017-10-30.
Number of Participants With Dose-limiting Toxicities (DLTs) = 1 Pts | Number of Participants With Dose-limiting Toxicities (DLTs) = 3 Pts
A Phase II, 2-Stage, 2-Arm PIK3CA Mutation Stratified Trial of MK-2206 in Recurrent or Advanced Endometrial Cancer
Study: NCT01307631 (CTgov). Phase: Phase 2. Enrollment: 37. Published: 2017-09-05.
Objective Tumor Response According to RECIST = 2 Pts
Pre-surgical Evaluation of MK-2206 in Patients With Operable Invasive Breast Cancer
Study: NCT01319539 (P5-03-03 | P2-03-01, CTgov). Phase: Phase 2. Enrollment: 12. Published: 2017-08-01.
Core(Mean) = 25 percentage of cells
A Randomized Phase 2 Study of MK-2206 in Comparison With Everolimus in Refractory Renal Cell Carcinoma
Study: NCT01239342 (CTgov). Phase: Phase 2. Enrollment: 43. Published: 2017-06-07.
Median Progression Free Survival (PFS) in Months(Median) = 3.68 Month (95%CI, 1.77 - 5.75) | Median Progression Free Survival (PFS) in Months(Median) = 5.98 Month (95%CI, 5.03 - NA)
Characterization of the tumor immune microenvironment (TIM) with multiplex immunohistochemistry (mIHC) in patients with breast cancer following treatment with MK-2206.
Study: NCT01319539 (ASCO2017). Phase: Phase 2. Enrollment: 10. Published: 2017-05-30.
Cytotoxic T-cells density = 87 % | Cytotoxic T-cells density = 0.2 %
A Phase 2 Study of MK-2206 in Previously Treated Metastatic Colorectal Cancer Patients Enriched for PTEN Loss and PIK3CA Mutation
Study: NCT01802320 (CTgov). Phase: Phase 2. Enrollment: 18. Published: 2017-05-30.
Overall Response Rate (CR+PR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 = 0 Pts
A Phase 2 Study of MK-2206 in Patients With Relapsed or Refractory Diffuse Large-B Cell Lymphoma
Study: NCT01481129 (CTgov). Phase: Phase 2. Enrollment: 22. Published: 2017-04-07.
Objective Response Rate According to the International Response Criteria for DLBCL (Cheson 2007) = 0 objective response
A randomized phase 2 study of MK-2206 versus everolimus in refractory renal cell carcinoma
Study: NCT01239342 (Pubmed | Ann Oncol). Phase: Phase 2. Enrollment: 43. Published: 2017-04-01.
PFS = 3.68 Month | PFS = 5.98 Month
Phase I/II Study of the Combination of Bendamustine, Rituximab and MK-2206 in the Treatment of Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Study: NCT01369849 (CTgov). Phase: Phase 1/2. Enrollment: 15. Published: 2016-06-28.
Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) = 1 Patients reporting Dose-Limiting Events | Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) = 2 Patients reporting Dose-Limiting Events
A Phase II Study of MK-2206 in the Treatment of Recurrent High-Grade Serous Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study: NCT01283035 (CTgov). Phase: Phase 2. Enrollment: 6. Published: 2016-06-24.
SD = 4 Pts
A Multi-Institutional Phase II Study of the Akt Inhibitor MK-2206 in Refractory Biliary Cancers
Study: NCT01425879 (CTgov). Phase: Phase 2. Enrollment: 8. Published: 2016-04-15.
Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1 = 0 Pts
Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs mFOLFOX in Patients With Metastatic Pancreatic Cancer After Prior Chemotherapy
Study: NCT01658943 (SWOG S1115 | S1115, CTgov). Phase: Phase 2. Enrollment: 137. Published: 2016-03-09.
OS(Median) = 6.7 Month (95%CI, 6.0 - 8.3) | OS(Median) = 3.9 Month (95%CI, 3.5 - 4.6)
A Phase II Clinical and Translational Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET)
Study: NCT01169649 (CTgov). Phase: Phase 2. Enrollment: 11. Published: 2016-02-18.
SD = 6 Pts
Phase II Trial of AKT Inhibitor MK2206 in Patients With Advanced Breast Cancer Who Have Tumors With a PIK3CA Mutation, or an AKT Mutation, and/or PTEN Loss/PTEN Mutation
Study: NCT01277757 (CTgov). Phase: Phase 2. Enrollment: 30. Published: 2016-02-12.
CR = 0 Pts
A Phase I Trial of Combined Ridaforolimus and MK-2206 in Patients with Advanced Malignancies
Study: NCT01295632 (8669-049, Pubmed | Clin Cancer Res). Phase: Phase 1. Enrollment: 35. Published: 2015-12-01.
CR(breast cancer) = 14.3 %
Phase II Study of MK-2206 in Patients With Relapsed Lymphoma
Study: NCT01258998 (CTgov). Phase: Phase 2. Enrollment: 60. Published: 2015-11-10.
Other (Not Including Serious) Adverse Events = 59 Pts
Phase II study of an AKT inhibitor MK2206 in patients with relapsed or refractory lymphoma
Study: NCT01258998 (Pubmed | Br J Haematol). Phase: Phase 2. Enrollment: 59. Published: 2015-11-01.
Adverse Event: Rash = Rash was the most common toxicity (any grade 53%, Grade 3 in 15%) and was observed in a dose-dependent manner
A Phase II Study of MK-2206 in Patients With Advanced Hepatocellular Carcinoma Who Have Failed or Are Intolerant of One Prior Line of Anti-angiogenic Therapy
Study: NCT01239355 (CTgov). Phase: Phase 2. Enrollment: 15. Published: 2015-10-05.
PFS(Median) = 1.7 Month (95%CI, 1.6 - 3.0)
Phase II Study of the AKT Inhibitor MK-2206 plus Erlotinib in Patients with Advanced Non-Small Cell Lung Cancer Who Previously Progressed on Erlotinib
Study: NCT01294306 (Pubmed | Clin Cancer Res). Phase: Phase 2. Enrollment: 80. Published: 2015-10-01.
DCR = 40 % | DCR = 47 %
Multicenter phase II study of the AKT inhibitor MK-2206 in recurrent or metastatic nasopharyngeal carcinoma from patients in the mayo phase II consortium and the cancer therapeutics research group (MC1079)
Study: NCT01370070 (MC1079, Pubmed | Invest New Drugs). Phase: Phase 2. Enrollment: 21. Published: 2015-08-01.
6-month PFS rate = 43 % (95%CI, 22 - 66)
Results of an abbreviated phase-II study with the Akt Inhibitor MK-2206 in Patients with Advanced Biliary Cancer
Study: NCT01425879 (Pubmed). Phase: Phase 2. Enrollment: 8. Published: 2015-07-10.
AE = Toxicities were mild and tolerable
Phase 2 study of MK-2206, an allosteric inhibitor of AKT, as second-line therapy for advanced gastric and gastroesophageal junction cancer: A SWOG cooperative group trial (S1005)
Study: NCT01260701 (S1005, Pubmed | Cancer). Phase: Phase 2. Enrollment: 70. Published: 2015-07-01.
mOS = 5.1 Month (95%CI, 3.7 - 9.4)
A Phase II Study of MK-2206 in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
Study: NCT01604772 (Alliance A091104, CTgov). Phase: Phase 2. Enrollment: 16. Published: 2015-06-26.
Confirmed Response Rate (Complete Response + Partial Response) According to RECIST Version 1.1 = 0 % (95%CI, 0 - 23.2)
Biomarker-driven phase 2 study of MK-2206 and selumetinib (AZD6244, ARRY-142886) in patients with colorectal cancer
Study: NCT01333475 (Pubmed | Invest New Drugs). Phase: Phase 2. Enrollment: 21. Published: 2015-06-01.
ORR = 0 %
Alliance A091104: A phase II trial of MK-2206 in patients (pts) with progressive, recurrent/metastatic adenoid cystic carcinoma.
Study: NCT01604772 (Alliance A091104, ASCO2015). Phase: Phase 2. Enrollment: 16. Published: 2015-05-20.
mPFS = 9.2 Month (95%CI, 0.6 - 33.3) | mPFS = 9.2 Month (95%CI, 3.8 - 11.0)
A Phase II Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer
Study: NCT01186705 (CTgov). Phase: Phase 2. Enrollment: 1. Published: 2015-04-21.
PD = 1 Pts
SU2C phase Ib study of paclitaxel and MK-2206 in advanced solid tumors and metastatic breast cancer
Study: NCT01263145 (Pubmed | Breast Cancer Res Treat). Phase: Phase 1. Enrollment: 22. Published: 2015-02-16.
RR = 5 Pts
Multicenter Phase II Study of MK-2206 in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma
Study: NCT01349933 (CTgov). Phase: Phase 2. Enrollment: 21. Published: 2015-01-08.
Alive and Progression Free = 9 Pts
A Phase 2 Study of the AKT Kinase Inhibitor MK-2206 in Patients With Relapsed Refractory Acute Myelogenous Leukemia
Study: NCT01253447 (CTgov). Phase: Phase 2. Enrollment: 19. Published: 2015-01-07.
CR = 0 Pts
Pilot Study of the Combination of MK-2206, an AKT Inhibitor, and AZD6244, a MEK Inhibitor, in Patients With Advanced Colorectal Carcinoma
Study: NCT01333475 (CTgov). Phase: Phase 2. Enrollment: 21. Published: 2014-12-04.
pAKT Baseline C1D1(Mean) = 4.86 pg/ µg of protein (Full Range, 1.89 - 7.41) | pAKT Baseline C1D1(Mean) = 0 pg/ µg of protein (Full Range, 0 - 0)
A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
Study: NCT01260701 (S1005, CTgov). Phase: Phase 2. Enrollment: 75. Published: 2014-08-04.
OS(Median) = 5 Month (95%CI, 4 - 9)
A Phase II Trial of MAP Kinase Inhibition With AZD6244 Hydrogen Sulfate in Combination With MK-2206 (Akt Inhibitor) in Patients With BRAF V600-Mutant Advanced Melanoma Whose Disease Has Progressed on Prior Therapy With a Selective BRAF Inhibitor (i.e., Vemurafenib, Dabrafenib, LGX818)
Study: NCT01519427 (CTgov). Phase: Phase 2. Enrollment: 2. Published: 2014-06-18.
CR = 0 Pts
Phase II, single stage, cohort expansion study of MK-2206 in recurrent endometrial serous cancer.
Study: ASCO2014. Phase: Phase 2. Enrollment: 14. Published: 2014-05-20.
Toxicity = rash, diarrhea, and anemia
A phase II study of MK-2206, an allosteric inhibitor of AKT as second-line therapy for advanced gastric and gastroesophageal junction (GEJ) cancer: A SWOG Cooperative Group trial (S1005).
Study: NCT01260701 (S1005, ASCO2014). Phase: Phase 2. Enrollment: 66. Published: 2014-05-20.
mOS = 5 Month
BATLLE-2: <i>KRAS</i> mutation and outcome in a biomarker-integrated study in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC).
Study: NCT01248247 (BATTLE-2, ASCO2014). Phase: Phase 2. Enrollment: 198. Published: 2014-05-20.
DCR = 20 % | DCR = 51 %
A phase I study of the AKT inhibitor MK-2206 plus hormonal therapy in postmenopausal women with estrogen receptor positive (ER+) metastatic breast cancer (MBC).
Study: NCT01344031 (ASCO2014). Phase: Phase 1. Enrollment: 31. Published: 2014-05-20.
Adverse Event: rash = Rash was common but incidence reduced with prophylactic prednisone | Adverse Event: rash = Rash was common but incidence reduced with prophylactic prednisone
Phase 1 trial of the oral AKT inhibitor MK-2206 plus carboplatin/paclitaxel, docetaxel, or erlotinib in patients with advanced solid tumors
Study: NCT00848718 (Pubmed | J Hematol Oncol). Phase: Phase 1. Enrollment: 72. Published: 2014-01-03.
MTD = 45 mg | MTD = 45 mg
A Phase Ib Dose-escalation Trial of the AKT Inhibitor MK2206 in Combination With Weekly Paclitaxel With or Without Trastuzumab
Study: NCT01235897 (CTgov). Phase: Phase 1. Enrollment: 17. Published: 2013-11-19.
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of MK-2206 Administered Weekly in Combination With Weekly Paclitaxel 80 mg/m^2 and Trastuzumab 2 mg/m^2 = 135 mg
A phase 1 study evaluating the combination of an allosteric AKT inhibitor (MK-2206) and trastuzumab in patients with HER2-positive solid tumors
Study: NCT00963547 (Pubmed | Breast Cancer Res). Phase: Phase 1. Enrollment: 34. Published: 2013-11-19.
MTD = 60 mg
A phase I study of MK-2206 in combination with lapatinib in patients (pts) with advanced solid tumors.
Study: NCT01245205 (ASCO2013). Phase: Phase 1. Enrollment: 23. Published: 2013-05-20.
MTD(maximum tolerated dose) = 60 mg
Randomized phase II CTEP study of MK2206 versus everolimus in VEGF inhibitor refractory renal cell carcinoma patients.
Study: NCT01239342 (ASCO2013). Phase: Phase 2. Enrollment: 43. Published: 2013-05-20.
mPFS = 3.65 Month (95%CI, 1.77 - 5.52) | mPFS = 7.43 Month (95%CI, 1.84 - 13.27)
A phase I dose escalation study of oral MK-2206 (allosteric Akt inhibitor) with oral selumetinib (AZD6244; ARRY-142866) (MEK 1/2 inhibitor) in patients with advanced or metastatic solid tumors.
Study: NCT01021748 (2206-010, ASCO2012). Phase: Phase 1. Enrollment: 51. Published: 2012-05-20.
SD = 24 Week | SD = 24 Week
First-in-Man Clinical Trial of the Oral Pan-AKT Inhibitor MK-2206 in Patients With Advanced Solid Tumors
Study: Pubmed | J Clin Oncol. Phase: Phase 1. Enrollment: Not disclosed. Published: 2011-12-10.
MTD(maximum-tolerated dose) = 60 mg
A randomized phase II study of MK-2206 in comparison with everolimus in refractory renal cell carcinoma.(NCI 8727).
Study: ASCO2011. Phase: Phase 2. Enrollment: 80. Published: 2011-05-20.
mPFS = 8.2 Month | mPFS = 4.9 Month
For every reported endpoint, obtain the protocol, statistical analysis plan, patient disposition, baseline characteristics, subgroup definitions, exposure duration, and full safety tables. Conference abstracts and registry summaries can support screening, but they should not replace source data review in a binding transaction.
Use PatSnap Life Sciences MCP servers to validate the MK-2206 diligence evidence.
4. Market and competitive position
The commercial case depends on differentiated efficacy, tolerability, convenience, biomarker reach, treatment setting, and access. A target-level market may be attractive while an individual asset remains undifferentiated. Benchmark MK-2206 against approved therapies and clinical competitors in Recurrent Prostate Carcinoma, including likely standards of care at the expected launch date.
Build a scenario model around addressable patients, diagnosis and biomarker rates, line of therapy, duration, net price, uptake, displacement, combination costs, and probability-adjusted timelines. Test slower enrollment, delayed readout, narrower labels, safety restrictions, and competitor launches.
Use PatSnap Life Sciences MCP servers to validate the MK-2206 diligence evidence.
5. Transaction precedent and economics
| Date | Transaction | Status | Type | Disclosed value |
|---|---|---|---|---|
| No exact asset-specific transaction was returned. Use target-level precedents only as comparables and do not present them as asset transactions. | ||||
Transaction records should be normalized for territory, asset scope, phase at signing, option mechanics, development obligations, cost sharing, royalties, milestones, and change-of-control terms. Undisclosed economics must not be converted into invented benchmarks.
6. IP and freedom-to-operate screen
Complete a family-level patent review covering composition of matter, sequence or construct claims, polymorph and salt claims, formulation, dosing, combinations, biomarkers, manufacturing, and method of use. Verify priority, ownership, assignments, prosecution status, term adjustments, extensions, oppositions, and regional coverage. Freedom to operate is a separate legal analysis and should include competitor claims and platform dependencies.
The diligence room should reconcile inventorship, employee and contractor assignments, university or platform licenses, sublicensing restrictions, government rights, and obligations triggered by development milestones or commercialization.
Use PatSnap Life Sciences MCP servers to validate the MK-2206 diligence evidence.
7. Principal risks and diligence gates
- Identity risk: resolve all aliases, formulations, combinations, and owners.
- Clinical risk: confirm source data, protocol deviations, endpoint definitions, and safety follow-up.
- Regulatory risk: review agency correspondence, meeting minutes, holds, commitments, and indication-specific pathways.
- IP risk: validate enforceable coverage, remaining life, ownership, and freedom to operate.
- CMC risk: assess process control, analytical methods, comparability, scale-up, supply, and cost of goods.
- Commercial risk: pressure-test differentiation, market access, competitive timing, and realistic adoption.
- Transaction risk: map rights, encumbrances, royalties, options, consent requirements, and change-of-control provisions.
8. Final go/no-go memorandum
CONDITIONAL GO
Proceed only through staged diligence. Before exclusivity or a binding offer, require a verified asset identity package, complete clinical data room, regulatory correspondence, patent-family schedule, freedom-to-operate opinion, CMC package, ownership chain, regional rights map, and risk-adjusted valuation. Any material mismatch between public records and source documents should pause the process until reconciled.
Method note: This report uses PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP data retrieved on 2026-10-14. It is a screening and diligence framework, not medical, legal, regulatory, or investment advice.
