Toxicological evaluations in non-human primates reveals a favorable safety profile, with no EGFR-related adverse effects observed at doses up to 120 mg/kg over 4 weeks. Supported by these preclinical findings, IBI334 has advanced to a phase 1 clinical trial (NCT05774873) for advanced/metastatic solid tumors.

10 days ago

Journal

EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • CD276 (CD276 Molecule)

EGFR positive

IBI-334

2ms

The Primary Objective of This Study to Evaluate the Safety and Tolerability of IBI334 and Determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D)and Anti Tumor Activity of IBI334. (clinicaltrials.gov)

P1/2, N=28, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Recruiting --> Completed | N=128 --> 28 | Trial completion date: Jun 2026 --> Mar 2025 | Trial primary completion date: Oct 2025 --> Mar 2025

2 months ago

Trial completion • Enrollment change • Trial completion date • Trial primary completion date

IBI-334

over2years

IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)

P1/2, N=128, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Phase classification: P1 --> P1/2

over 2 years ago

Phase classification

RAS (Rat Sarcoma Virus)

RAS wild-type

IBI-334

over2years

IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)

P1, N=128, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting

over 2 years ago

Enrollment open • Metastases

RAS (Rat Sarcoma Virus)

RAS wild-type

IBI-334

almost3years

IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)

P1, N=128, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.

almost 3 years ago

New P1 trial • Metastases

RAS (Rat Sarcoma Virus)

RAS wild-type

IBI-334