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Recruiting NCT06621563

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

Phase I Interventional Solid Tumors Non-Small Cell Lung Cancer Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HS-20117 combined HS-20093, HS-20117 combined Platinum-containing chemotherapy, HS-20117 combined HS-20093 and 5-FU, HS-20117+CAPEOX.
Who it may be relevant to
Registry conditions: Solid Tumors, Non-Small Cell Lung Cancer, Colorectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Safety, Tolerability, Efficacy, Pharmacokinetics Profile and Immunogenicity of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors, a Phase Ib Clinical Trial

Overview

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.

Detailed 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.

Interventions

  • Drug HS-20117 combined HS-20093
    HS-20117 + HS-20093
  • Drug HS-20117 combined Platinum-containing chemotherapy
    HS-20117 + cisplatin/carboplatin + pemetrexed
  • Drug HS-20117 combined HS-20093 and 5-FU
    HS-20117 + HS-20093 + 5-FU
  • Drug HS-20117+CAPEOX
    CAPOEX: Oxaliplatin+Capecitabine
  • Drug HS-20117+FOLFIRI
    FOLFIRI=Irinotecan+Leucovorin Calcium+5-FU
  • Drug HS-20117+mFOLFOX6
    mFOLFOX6=Oxaliplatin+Leucovorin Calcium+5-FU

Primary outcome measures

  • Incidence and severity of treatment-emergent adverse events [Time frame: 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. [Time frame: From the date of first dose to day 21.]
Secondary outcome measures (10)
  • Efficacy of HS-20117: Objective response rate (ORR) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years]
  • PK parameters: Trough serum concentration (Ctrough) of HS-20117 and HS-20093 [Time frame: From the date of first dose to 90 days after the final dose.]
  • PK parameters: Time to reach maximum observed serum concentration (Tmax) of HS-20117 [Time frame: From the date of first dose to 90 days after the final dose.]
  • PK parameters: Area under the curve from time Zero to end of dosing interval (AUCtau) of HS-20117 [Time frame: From the date of first dose to 90 days after the final dose.]
  • PK parameters: Maximum serum concentration (Cmax) of HS-20117 and HS-20093. [Time frame: From the date of first dose to 90 days after the final dose.]
  • Immunogenicity of HS-20117 [Time frame: From the date of first dose to 90 days after the final dose.]

Eligibility criteria

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:
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute & Hospital — Tianjin

Identifiers

NCT: NCT06621563 · HS-20117-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗