Open-Label, Global, Multicenter, Randomized, Phase 2/3 Study of AMT-116 Versus Investigator's Choice in Participants With Advanced or Metastatic Non-squamous EGFR-Wildtype Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

This clinical trial consists of two parts: phase 2 and phase 3.
The goal of phase 2 of this clinical trial is to compare which dose level of AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype non-small cell lung cancer (NSCLC) in adults. It will also learn about the safety of AMT-116. The main questions it aims to answer are:
* Which level of AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype NSCLC?
* What medical problems do participants have when taking AMT-116? The goal of phase 3 of this clinical trial is to compare AMT-116 to study doctor's choice (a kind of retainable treatment for you in the opinion of the study doctor) to see if AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype NSCLC.
In both parts of this trial, participants will receive AMT-116 or study doctor's choice every 2 weeks until the study doctor thinks you are benefiting from your participation or until your disease progresses or you are unable to tolerate the study drug

Start Date28 Aug 2026

Sponsor / Collaborator

Multitude Therapeutics, Inc.

NCT07590531

/ RecruitingPhase 1/2

An Open-label, Multicenter Phase Ib/II Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMT116 in Combination With Ivosimab (AK112) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the safety and efficacy of AMT-116 in combination with ivosidan (AK112) in patients with advanced non-small cell lung cancer (NSCLC). The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.

Start Date29 Jun 2026

Sponsor / Collaborator

Multitude Therapeutics, Inc.

NCT06782334

/ RecruitingPhase 1/2

Phase 1/2 Study of AMT-116 in Patients with Advanced Solid Tumors

The purpose of this study is to evaluate the safety and efficacy of AMT-116 monotherapy in subjects with advanced solid tumors. The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.

Start Date07 May 2024

Sponsor / Collaborator

Multitude Therapeutics, Inc.

100 Clinical Results associated with AMT-116(Multitude Therapeutics)

100 Translational Medicine associated with AMT-116(Multitude Therapeutics)

100 Patents (Medical) associated with AMT-116(Multitude Therapeutics)

100 Deals associated with AMT-116(Multitude Therapeutics)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	Multitude Therapeutics, Inc.	28 Aug 2026
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	Multitude Therapeutics, Inc.	28 Aug 2026
metastatic non-small cell lung cancer	Phase 3	United States	Multitude Therapeutics, Inc.	28 Aug 2026
metastatic non-small cell lung cancer	Phase 3	Australia	Multitude Therapeutics, Inc.	28 Aug 2026
Advanced Malignant Solid Neoplasm	Phase 2	China	Multitude Therapeutics, Inc. (China)	24 Apr 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06782334 \| NCT05725291 (PRNewswire \| ESMO2025) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	164	AMT-116 (all doses)	tmyaowevyn(tpjixultuk) = aeidxlposw devwecccgd (tdxhsyfuvm ) View more	Positive	17 Oct 2025
				AMT-116 (≥3 mg/kg)	tmyaowevyn(hvsvmathdm) = ocftjofojl chmcblfdci (fexfwsqhpu ) View more
NCT05725291 (AMT-116-01, ESMO2025)	Phase 1/2	Advanced Malignant Solid Neoplasm	102	AMT-116	itahvuugkg(jjiruizlar) = bandrapzdp ssvqqvbcgk (clyyutzupg ) View more	Positive	17 Oct 2025
				AMT-116 (EGFR wild-type NSCLC)	zwubmrvnii(nudmbogurp) = hifflrtmyr hhkjsxigui (enqalqxuyu ) View more
NCT05725291 (ASCO2024)	Phase 1	Advanced Malignant Solid Neoplasm CD44v9	8	AMT-116 3 mg/kg	fstiuhlwtr(vljumqoyln) = No DLT events were observed dkzxnswjjm (fsnrngyudt ) View more	Positive	24 May 2024

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