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

NCT06621563 | Recruiting Phase 1

• 1 other identifier: HS-20117-102
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Solid tumor; EGFR/c-MET bispecific antibody; B7H3 ADC; chemotherapy

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of treatment-emergent adverse events

  Adverse event (assessed according to NCI CTCAE v5.0) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  rom the date of first dose to 90 days after the final dose.

• Tolerability of HS-20117 combination therapy: incidence of DLT events, maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20117 in combination therapies.

  MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT. MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.

  From the date of first dose to day 21.

Secondary Outcomes (10)

• Efficacy of HS-20117: Objective response rate (ORR)

  From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years

• Efficacy of HS-20117: disease control rate (DCR)

  From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years

• Efficacy of HS-20117: duration of response (DoR)

  From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years

• Efficacy of HS-20117: progression free survival (PFS)

  From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years

• Efficacy of HS-20117: overall survival (OS)

  From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years

Study Arms (6)

Cohort 1a

EXPERIMENTAL

NSCLC

Drug: HS-20117 combined Platinum-containing chemotherapy

Cohort 2a

EXPERIMENTAL

NSCLC

Drug: HS-20117 combined HS-20093

Cohort 3a

EXPERIMENTAL

CRC

Drug: HS-20117+CAPEOX

Cohort 4a

EXPERIMENTAL

CRC

Drug: HS-20117+FOLFIRI

Cohort 5a

EXPERIMENTAL

CRC

Drug: HS-20117+mFOLFOX6

Cohort 6a

EXPERIMENTAL

CRC

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

Interventions

HS-20117 combined HS-20093 DRUG

HS-20117 + HS-20093

Cohort 2a

HS-20117 combined Platinum-containing chemotherapy DRUG

HS-20117 + cisplatin/carboplatin + pemetrexed

Cohort 1a

HS-20117 combined HS-20093 and 5-FU DRUG

HS-20117 + HS-20093 + 5-FU

Cohort 6a

HS-20117+CAPEOX DRUG

CAPOEX: Oxaliplatin+Capecitabine

Cohort 3a

HS-20117+FOLFIRI DRUG

FOLFIRI=Irinotecan+Leucovorin Calcium+5-FU

Cohort 4a

HS-20117+mFOLFOX6 DRUG

mFOLFOX6=Oxaliplatin+Leucovorin Calcium+5-FU

Cohort 5a

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Received or are receiving the following treatments:
• Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates.
• Monoclonalor bispecific antibodies targeting EGFR.
• Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117.
• Investigational anti-cancer drugs or antibodies or ADCs within 4 weeks prior to the first dose of HS-20117.
• 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.
• Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
• 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.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Xiaowei Yan

CONTACT

13061877102; yanxw@hspharm.com

Study Design

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

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 1, 2024
• Study Start: December 14, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)