TQB2922 and TAS-102 Tablets for Injection With or Without Bevacizumab in Chemotherapy-failed RAS/BRAF Wild-type Advanced Colorectal Cancer

Conditions

• RAS/BRAF Wild Type Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• TQB2922 injection ± TAS-102 tablets — DRUG
  TQB2922 is an anti-EGFR/c-Met bispecific antibody, subtype Immunoglobulin G1 (IgG1). TQB2922 blocks the activation of EGFR and c-Met signalling pathway by binding to EGFR and c-Met on the surface of tumour cells, thus preventing tumour growth and progression. At the same time, TQB2922 can target EGFR and c-Met on the surface of tumour cells through antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell phagocytosis by natural killer cells and macrophages, thus killing tumour cells.
• TQB2922 injection+TAS-102 tablets ± Bevacizumab — DRUG
  TQB2922 is an anti-EGFR/c-Met bispecific antibody, subtype IgG1. TQB2922 blocks the activation of EGFR and c-Met signalling pathway by binding to EGFR and c-Met on the surface of tumour cells, thus preventing tumour growth and progression. At the same time, TQB2922 can target EGFR and c-Met on the surface of tumour cells through antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell phagocytosis by natural killer cells and macrophages, thus killing tumour cells.

Study Details

This is a multicenter, open Phase Ib/II clinical study evaluating the safety and efficacy of TQB2922 in combination with TAS-102±bevacizumab in subjects with RAS/BRAF wild-type unresectable locally advanced or metastatic colorectal cancer that has failed treatment with oxaliplatin, fluorouracil-based and irinotecan.

Key Dates

First listed

Jul 1, 2025

Start date

Jul 30, 2025

Status verified

Apr 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2027

Study Design

Enrollment

72 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: TQB2922 injection + TAS-102 tablets
  Phase Ib: TQB2922 injection + TAS-102 tablets; TQB2922 is administered in the appropriate dose group, intravenously, every 28 days, once weekly in cycle 1 and every 2 weeks starting in cycle 2; TAS-102 tablets are administered at 35 mg/m2 (maximum 80 mg in a single dose), orally, twice daily, repeated every 28 days, on days 1 to 5 and 8 to 12. The dosage will be repeated every 28 days.
• Experimental: TQB2922 injection
  Phase Ib: TQB2922 injection; TQB2922 is administered in the appropriate dose group, intravenously, every 28 days, once weekly in cycle 1 and every 2 weeks starting in cycle 2; TAS-102 tablets are administered at 35 mg/m2 (maximum 80 mg in a single dose), orally, twice daily, repeated every 28 days, on days 1 to 5 and 8 to 12. The dosage will be repeated every 28 days.
• Experimental: TQB2922 injection+TAS-102 tablets + Bevacizumab
  Phase II: TQB2922 injection + TAS-102 tablets + bevacizumab; TQB2922 will be administered according to Recommended Phase 2 Dose (RP2D), one treatment cycle every 28 days, and once a week in the first cycle. TQB2922 was administered according to RP2D, one treatment cycle every 28 days, once a week in the 1st cycle, and once every 2 weeks starting from the 2nd cycle; TAS-102 tablets were administered at 35 mg/m2 (maximum 80 mg in a single dose) orally twice a day on days 1-5 and 8-12, and repeated every 28 days; bevacizumab was administered at 5 mg/kg intravenously on the 1st day, and repeated every 2 weeks.
• Experimental: TQB2922 injection+TAS-102 tablets
  Phase II: TQB2922 injection + TAS-102 tablets; TQB2922 will be administered according to RP2D, one treatment cycle every 28 days, and once a week in the first cycle. TQB2922 was administered according to RP2D, one treatment cycle every 28 days, once a week in the 1st cycle, and once every 2 weeks starting from the 2nd cycle; TAS-102 tablets were administered at 35 mg/m2 (maximum 80 mg in a single dose) orally twice a day on days 1-5 and 8-12, and repeated every 28 days; bevacizumab was administered at 5 mg/kg intravenously on the 1st day, and repeated every 2 weeks.

Primary Outcome Measure

Dose limiting toxicity (DLT) [ Time Frame: Baseline up to 48 weeks ]

Central Contacts

• Suxia Luo, Master
  18638553211
  [email protected]
• Shegan Gao, Doctor
  18639859977
  [email protected]