Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

NCT05504278 | Recruiting Phase 1

• 1 other identifier: CIBI351A301
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation.

Conditions

Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Number of participants with dose limiting toxicity

  Number of participants with dose limiting toxicity in the dose escalation period

  12 months

• Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents

  Objective response rate per RECIST v1.1

  24 months

• Safety indicators during the introduction phase for IBI351 combination treatment :

  Number of participants with Adverse events (AE), Treatment Emergent Adverse events (TEAE), treatment-related Adverse events (TEAE), TRAE) and the incidence of Serious Adverse events (SAE) (CTCAE v5.0 standard), with abnormal vital signs, abnormal physical exams, abnormal laboratory results and abnormal 12-lead electrocardiogram

  24 months

Secondary Outcomes (11)

• Evaluate plasma peak concentration of IBI351

  12 months

• Evaluate area under the plasma concentration-time curve (AUC) of IBI351

  12 months

• Evaluate terminal half-life (t1/2) of IBI351

  12 months

• Evaluate clearance of IBI351 from the plasma

  12 months

• Evaluate distribution of IBI351

  12 months

Study Arms (5)

IBI351 in combination with pemetrexed and cis-platinum/carboplatin (the subject with PD-L1 TPS<1%)

EXPERIMENTAL

Drug: IBI351; Drug: pemetrexed; Drug: Carboplatin; Drug: cis-platinum

IBI351 in combination with Cetuximab

EXPERIMENTAL

Drug: IBI351; Drug: Cetuximab

IBI351 monotherapy

EXPERIMENTAL

Drug: IBI351

IBI351 in combination with Sintilimab

EXPERIMENTAL

Drug: IBI351; Drug: Sintilimab

IBI351 in combination with pemetrexed and cis-platinum/carboplatin(the subject with PD-L1 TPS 1-49%)

EXPERIMENTAL

Drug: IBI351; Drug: pemetrexed; Drug: Carboplatin; Drug: cis-platinum

Interventions

IBI351 DRUG

recommended dose, po

Also known as: GFH925

IBI351 in combination with Cetuximab; IBI351 in combination with Sintilimab; IBI351 in combination with pemetrexed and cis-platinum/carboplatin (the subject with PD-L1 TPS<1%); IBI351 in combination with pemetrexed and cis-platinum/carboplatin(the subject with PD-L1 TPS 1-49%); IBI351 monotherapy

Cetuximab DRUG

500mg/m\^2, Q2W, day1, i.v.

IBI351 in combination with Cetuximab

pemetrexed DRUG

500mg/m\^2, Q3W, day1, i.v.

IBI351 in combination with pemetrexed and cis-platinum/carboplatin (the subject with PD-L1 TPS<1%); IBI351 in combination with pemetrexed and cis-platinum/carboplatin(the subject with PD-L1 TPS 1-49%)

Carboplatin DRUG

AUC=5, Q3W, day1, i.v.

IBI351 in combination with pemetrexed and cis-platinum/carboplatin (the subject with PD-L1 TPS<1%); IBI351 in combination with pemetrexed and cis-platinum/carboplatin(the subject with PD-L1 TPS 1-49%)

Sintilimab DRUG

200mg, Q3W, day1, i.v.

Also known as: IBI308

IBI351 in combination with Sintilimab

cis-platinum DRUG

75mg/m\^2, Q3W, day1, i.v.

IBI351 in combination with pemetrexed and cis-platinum/carboplatin (the subject with PD-L1 TPS<1%); IBI351 in combination with pemetrexed and cis-platinum/carboplatin(the subject with PD-L1 TPS 1-49%)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation
• Unresectable or metastatic disease
• Adequate organ function
• Not received any systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC previously.

You may not qualify if:

• History of intestinal disease or major gastric surgery or inability to swallow oral medications
• Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).
• Active brain metastases.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Jilin Province Cancer Hospital

Jilin, Changchun, China

RECRUITING

MeSH Terms

Interventions

Cetuximab; Pemetrexed; Carboplatin; sintilimab; Cisplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Haiyan Zhu

CONTACT

0512-69566088; haiyan.zhu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 17, 2022
• Study Start: September 20, 2022
• Primary Completion: May 31, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

CN (1)