Clinical trial NCT06621563: Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Non-Small Cell Lung Cancer
Colorectal Cancer
Keywords: Solid tumor
EGFR/c-MET bispecific antibody
B7H3 ADC
chemotherapy
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

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 \&amp;amp;gt; 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.

Primary outcomes:
measure: Incidence and severity of treatment-emergent adverse events
timeFrame: rom the date of first dose to 90 days after the final dose.
measure: 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.
timeFrame: From the date of first dose to day 21.
Secondary outcomes:
measure: Efficacy of HS-20117: Objective response rate (ORR)
timeFrame: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years
measure: Efficacy of HS-20117: disease control rate (DCR)
timeFrame: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years
measure: Efficacy of HS-20117: duration of response (DoR)
timeFrame: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years
measure: Efficacy of HS-20117: progression free survival (PFS)
timeFrame: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years
measure: Efficacy of HS-20117: overall survival (OS)
timeFrame: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years
measure: PK parameters: Trough serum concentration (Ctrough) of HS-20117 and HS-20093
timeFrame: From the date of first dose to 90 days after the final dose.
measure: PK parameters: Time to reach maximum observed serum concentration (Tmax) of HS-20117
timeFrame: From the date of first dose to 90 days after the final dose.
measure: PK parameters: Area under the curve from time Zero to end of dosing interval (AUCtau) of HS-20117
timeFrame: From the date of first dose to 90 days after the final dose.
measure: PK parameters: Maximum serum concentration (Cmax) of HS-20117 and HS-20093.
timeFrame: From the date of first dose to 90 days after the final dose.
measure: Immunogenicity of HS-20117
timeFrame: From the date of first dose to 90 days after the final dose.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
Study officials:
References: