A Study of HS-20124 in Patients with Advanced Solid Tumors

NCT06763159 | Recruiting Phase 1

• 1 other identifier: HS-20124-101
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

HS-20124 is a novel DAR-8 antibody-drug conjugate （ADC） targeting CDH6. In preclinical studies, it inhibited tumor cell growth expressing CDH6 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20124 in Patients With Advanced Solid Tumors.

Conditions

Solid Cancer

Outcome Measures

Primary Outcomes (2)

• Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of complete response (CR) an

  To determine the MTD/MAD for further evaluation of IV administration of HS-20124 in subjects with advanced solid tumors

  3 weeks after initiation of treatment

• Ⅰb (Dose-Expansion Stage): Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of complete response (CR) and partial response (PR) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]

  From the first dose up to PD or withdrawal from study, whichever came first.

Secondary Outcomes (8)

• Incidence and severity of treatment-emergent adverse events

  From the first dose through 30 days post end of treatment

• Observed maximum plasma concentration (Cmax)

  At the end of Cycle 1 (each cycle is 21 days)

• Time to reach maximum plasma concentration (Tmax)

  At the end of Cycle 1 (each cycle is 21 days)

• Terminal half-life (T1/2)

  At the end of Cycle 1 (each cycle is 21 days)

• Percentage of participants with antibodies to HS-20124 in serum

  At the end of Cycle 1 (each cycle is 21 days)

Study Arms (2)

HS-20124 (Phase Ia：Dose escalation )

EXPERIMENTAL

HS-20124 for IV infusion of various dose strengths administered in 21 day dosing cycles

Drug: HS-20124 (Phase Ia：Dose escalation )

HS-20124 (Phase Ib: Dose expansion)

EXPERIMENTAL

The recommended dose from the dose-escalation stage and other potential doses will be further explored

Drug: HS-20124 (Phase Ib: Dose expansion)

Interventions

HS-20124 (Phase Ia：Dose escalation ) DRUG

Participants will receive HS-20124 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

HS-20124 (Phase Ia：Dose escalation )

HS-20124 (Phase Ib: Dose expansion) DRUG

Participants will receive HS-20124 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

HS-20124 (Phase Ib: Dose expansion)

Eligibility Criteria

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

You may qualify if:

• At least age of 18 years at screening;
• Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable
• At least one extra-cranial measurable lesion according to RECIST 1
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1
• Life expectancy \>= 12 weeks
• Men or women should be using adequate contraceptive measures throughout the study;
• Females subjects must not be pregnant at screening or have evidence of non-childbearing potential
• Signed and dated Informed Consent Form

You may not qualify if:

• Treatment with any of the following:
• Previous or current treatment with CDH6 targeted therapy
• Any cytotoxic chemotherapy and small molecule targeted anticancer drugs within 21 days or five half-livesprior to the first scheduled dose of HS-20124
• Prior treatment with a monoclonal antibody or investigational agents within 28 days prior to the first scheduled dose of HS-20124
• Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20124
• Major surgery within 4 weeks prior to the first scheduled dose of HS-20124 2. Subjects with previous or concurrent malignancies 3. Inadequate bone marrow reserve or organ dysfunction 4. Evidence of cardiovascular risk 5. Evidence of current severe or uncontrolled systemic diseases 6. Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20124 7. Severe infection within 4 weeks prior to the first scheduled dose of HS-20124 8. Subjects with current infectious diseases 9. History of neuropathy or mental disorders 10. Pregnant or lactating female 11. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20124 or any of the components of HS-20124

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Affiliated Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

Central Study Contacts

Xiaohua Wu, Doctor

CONTACT

021-64175590-88503; JJYIN555@163.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: November 8, 2024
• First Posted: January 8, 2025
• Study Start: October 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2025

Record last verified: 2024-11

Locations

CN (1)