^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    tecaginlimab (GEN1042)

    i
    Other names: BNT 312, GEN 1042, BNT-312, GEN-1042, GEN1042 , BNT312, DuoBody-CD40x4-1BB
    Associations

    News

    Trials
    Company:
    BioNTech, Genmab
    Drug class:
    CD137 agonist, CD40 agonist
    Related drugs:
    Associations

    News

    Trials
    1m
    A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=13, Terminated, Genmab | N=88 --> 13 | Active, not recruiting --> Terminated; After reviewing all available data from Part 1 of the trial, the Sponsor has decided not to proceed to Part 2 (randomized Phase 2) of the trial due to lack of efficacy
    Enrollment change • Trial termination
    |
    Keytruda (pembrolizumab) • tecaginlimab (GEN1042)
    2ms
    GCT1042-01: GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=350, Active, not recruiting, Genmab | N=1287 --> 350 | Trial completion date: Aug 2026 --> Nov 2026
    Enrollment change • Trial completion date • First-in-human
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • pemetrexed • tecaginlimab (GEN1042)
    5ms
    GCT1042-01: GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=1287, Active, not recruiting, Genmab | Trial primary completion date: Sep 2025 --> Dec 2025
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • pemetrexed • tecaginlimab (GEN1042)
    6ms
    A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=42, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • tecaginlimab (GEN1042)
    7ms
    Dose Selection for DuoBody®-CD40x4-1BB (GEN1042/BNT312) Using a mPBPK/RO Model Leveraging Preclinical and Clinical Data. (PubMed, Clin Pharmacol Ther)
    An initial expansion dose of GEN1042 100 mg every 3 weeks was chosen based on available clinical safety/tolerability, efficacy, PK/pharmacodynamics data, mPBPK/RO, and exposure-response analysis. This dose level is currently being evaluated in combination with pembrolizumab, with or without chemotherapy, in the expansion phase of the GEN1042 phase 1/2 trial (NCT04083599); other alternative doses are currently being explored.
    Clinical data • Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD40 (CD40 Molecule)
    |
    Keytruda (pembrolizumab) • tecaginlimab (GEN1042)
    7ms
    GCT1042-01: GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=1287, Active, not recruiting, Genmab | Trial completion date: Sep 2025 --> Aug 2026 | Trial primary completion date: Jun 2025 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • pemetrexed • tecaginlimab (GEN1042)
    7ms
    A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=88, Active, not recruiting, Genmab | Trial completion date: Jul 2026 --> Nov 2025 | Trial primary completion date: Jul 2026 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • tecaginlimab (GEN1042)
    10ms
    GCT1042-01: GEN1042 Safety Trial and Anti-tumor Activity in Participants with Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=1287, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • pemetrexed • tecaginlimab (GEN1042)
    12ms
    A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=42, Recruiting, Genmab | N=30 --> 42 | Trial primary completion date: Jul 2026 --> Mar 2026
    Enrollment change • Trial primary completion date
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • tecaginlimab (GEN1042)
    1year
    A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=88, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    Keytruda (pembrolizumab) • tecaginlimab (GEN1042)
    over1year
    A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=30, Recruiting, Genmab | Trial completion date: Oct 2027 --> Feb 2027
    Trial completion date • Combination therapy
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • tecaginlimab (GEN1042)
    almost2years
    GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=1287, Recruiting, Genmab | N=647 --> 1287 | Trial primary completion date: Oct 2025 --> Jul 2025
    Enrollment change • Trial primary completion date
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • pemetrexed • tecaginlimab (GEN1042)