Last update 09 Dec 2025

Nadunolimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Nidanilimab, CAN-04, CAN04
Target
Action
inhibitors, stimulants
Mechanism
IL1RAP inhibitors(Interleukin-1 receptor accessory protein inhibitors), Natural killer cells stimulants(Natural killer cells stimulants)
Originator Organization
Active Organization
Inactive Organization-
License Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationFast Track (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pancreatic CancerPhase 2
United States
20 Feb 2024
Advanced Triple-Negative Breast CarcinomaPhase 2
Spain
11 Jan 2022
Advanced Malignant Solid NeoplasmPhase 2
France
22 Sep 2021
Advanced Malignant Solid NeoplasmPhase 2
Spain
22 Sep 2021
Gallbladder NeoplasmsPhase 2
France
22 Sep 2021
Gallbladder NeoplasmsPhase 2
Spain
22 Sep 2021
Intrahepatic CholangiocarcinomaPhase 2
France
22 Sep 2021
Intrahepatic CholangiocarcinomaPhase 2
Spain
22 Sep 2021
Non-Small Cell Lung CancerPhase 2
France
22 Sep 2021
Colorectal CancerPhase 2
Austria
19 Sep 2017
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
Advanced Triple-Negative Breast Carcinoma
HER2 Negative | PR Negative | ER Negative
99
tztvyxuufg(ekebktkkbr) = zvlrqybrzh bsthqkpoqn (ctfgzrdubn )
Negative
18 Jul 2025
Gemcitabine+Carboplatin
tztvyxuufg(ekebktkkbr) = yyulamnmzl bsthqkpoqn (ctfgzrdubn )
Phase 1/2
15
xjzbpdghxv(ztserbrkkg) = zdiyzjzokg vtrtoanfqt (vbfwzydfjw, 32 - 84)
Positive
10 Dec 2024
Phase 1/2
-
Nadunolimab in combination with gemcitabine/cisplatin
(NSCLC + first arm)
nmjkqbsnqb(bwosgeaewb) = zpiorhiqgn qttfqajrsg (akippxfozy )
Positive
28 Oct 2024
Nadunolimab in combination with gemcitabine/cisplatin
(biliary tract cancer + first arm)
nmjkqbsnqb(bwosgeaewb) = shqlaeikfv qttfqajrsg (akippxfozy )
Phase 1/2
Non-Small Cell Lung Cancer
First line | Second line
40
ckpcyakfjt(qqifcwlyxx) = dyftmyfbuy bsbmmrnrvp (yeeygkibvl )
Positive
14 Sep 2024
ckpcyakfjt(qqifcwlyxx) = wywnqinbph bsbmmrnrvp (yeeygkibvl )
Phase 1
15
ykxtzpxoax(nyqcxdrxmt) = 1(G3 febrile neutropenia) fvgsgihciv (urjlheykry )
Positive
14 Sep 2024
Phase 1/2
73
ahwecempby(bdfuzueech) = nzrghkuhnz pmacirkbje (bdvzxqcfhi )
Positive
24 May 2024
ahwecempby(bdfuzueech) = bxrerbmhog pmacirkbje (bdvzxqcfhi )
Phase 1/2
Triple Negative Breast Cancer
HER2 Negative | ER Negative | PR Negative
13
nadunolimab++gemcitabine 1000 mg/m2+carboplatin 2 mg/mL/min
(Nadunolimab 1 mg/kg)
ixlkzqnzxv(eppkiuuquf) = xdtrkjxfqp noltqhnjja (gijwcprihq )
Positive
21 Oct 2023
nadunolimab++gemcitabine 1000 mg/m2+carboplatin 2 mg/mL/min
(Nadunolimab 2.5 mg/kg)
ixlkzqnzxv(eppkiuuquf) = dkzuoppade noltqhnjja (gijwcprihq )
Phase 1/2
30
Nadunolimab 1 mg/kg + cisplatin/gemcitabine
elsjrbimmq(kwldwhptbu) = pinizidytn czgwvrjzzs (nsgukzejxn, 3.7 - 7.5)
Positive
31 May 2023
Nadunolimab 2.5 mg/kg + cisplatin/gemcitabine
xtgowdvuym(cvtehzfkgi) = tuufnmnhjo kyjmbiublp (deadfrhzrd )
Phase 1/2
73
gsfantuhzz(sjsipejnng) = xmpgwhyvis tzimchsnqs (qcytdwzzky, 10.0 - 19.1)
-
04 Apr 2023
Phase 1/2
76
ihmzdifakl(kthkyetiiq) = Infusion-related reactions were reported in 29% (grade 3 in 3%). Peripheral sensory neuropathy was rare (only two grade 2 events). akcauyymaa (jbkohdsnld )
Positive
02 Jun 2022
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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