Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors

Hansoh Pharma

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors; Colorectal Cancer; Non-Small Cell Lung Cancer

Treatments: Drug: HS-20117+mFOLFOX6; Drug: HS-20117 combined HS-20093 and 5-FU; Drug: HS-20117 combined Platinum-containing chemotherapy; Drug: HS-20117 combined HS-20093; Drug: HS-20117+FOLFIRI; Drug: HS-20117+CAPEOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT06621563

HS-20117-102

Details and patient eligibility

About

HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.

Full description

This is a multicenter, open-label, Phase Ib clinical trial of HS-20117 combination therapies to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity in participants with advanced solid tumors. The study includes a dose escalation part and a dose expansion part. The dose-escalation study will be performed to evaluate the safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 combination therapies in participants with advanced solid tumor. The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 combination therapies in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations or EGFR classical mutations, and RAS/BRAF V600E wild type CRC.

Enrollment: 780 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females aged 18 - 75 years (inclusive).
• Histologically confirmed unresectable, recurrent or metastatic solid tumors.
• At least one target lesion per the RECIST v1.1.
• ECOG performance status of 0-1.
• Minimum life expectancy > 12 weeks.
• Males or Females should be using adequate contraceptive measures throughout the study.
• Females must not be pregnant at screening or have evidence of non-childbearing potential.
• Signed Informed Consent Form.

Exclusion criteria

• Received or are receiving the following treatments:

  1. Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates.
  2. Monoclonalor bispecific antibodies targeting EGFR.
  3. Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117.
  4. Investigational anti-cancer drugs or antibodies or ADCs within 4 weeks prior to the first dose of HS-20117.
  5. Local radiotherapy within 2 weeks prior to the first dose of HS-20117, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of HS-20117.
  6. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
  7. Major surgery within 4 weeks prior to the first dose of HS-20117.

• Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.

• Presence of uncured secondary primary malignancies.

• Untreated, or active central nervous system metastases.

• Severe, uncontrolled or active cardiovascular disorders.

• Serious infection within 4 weeks prior to the first dose of HS-20117.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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780 participants in 6 patient groups

Cohort 1a

Experimental group

Description:

NSCLC

Treatment:

Drug: HS-20117 combined Platinum-containing chemotherapy

Cohort 2a

Experimental group

Description:

NSCLC

Treatment:

Drug: HS-20117 combined HS-20093

Cohort 3a

Experimental group

Description:

CRC

Treatment:

Drug: HS-20117+CAPEOX

Cohort 4a

Experimental group

Description:

CRC

Treatment:

Drug: HS-20117+FOLFIRI

Cohort 5a

Experimental group

Description:

CRC

Treatment:

Drug: HS-20117+mFOLFOX6

Cohort 6a

Experimental group

Description:

CRC

Treatment:

Drug: HS-20117 combined HS-20093 and 5-FU