Study of HS-20105 for Injection in Patients With Advanced Solid Tumors.

NCT06144723 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-20105-101
• Study Type: interventional
• Target: 402
• Locations: 0 countries
• Sites: N/A

Brief Summary

HS-20105 is a novel antibody-drug conjugate (ADC) targeting Trop-2. This first-in-human trial is aimed to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics (PK), safety and preliminary anti-tumor activity of HS-20105 in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumor; HS-20105; Trop-2; ADC

Outcome Measures

Primary Outcomes (2)

• Phase Ia: MTD or maximum applicable dose (MAD) of HS-20105

  Number of participants with DLT.

  Up to12 months.

• Phase Ib: Efficacy of HS-20105

  Objective response rate (ORR) according to response evaluation criteria in solid tumors (RECIST) 1.1 by investigator's assessment.

  Up to 24 months.

Secondary Outcomes (10)

• Incidence and severity of treatment-emergent adverse events

  Up to 36 months.

• Disease control rate (DCR)

  Up to 24 months.

• Duration of response (DoR)

  Up to 24 months.

• Progression-free survival (PFS)

  Up to 24 months.

• Overall survival (OS)

  Up to 3 years

Study Arms (2)

HS-20105 Phase Ia (Dose escalation)

EXPERIMENTAL

Patients with advanced solid tumors will be enrolled and receive HS-20105 of various dose strengths until the end of the study in the absence of unacceptable toxicities and disease progression.

Drug: HS-20105

HS-20105 Phase Ib (Dose expansion)

EXPERIMENTAL

Depending on data obtained from the dose escalation, dose expansion may proceed with multiple cohorts in subjects with advanced solid tumors. Patients enrolled will receive HS-20105 until the end of the study in the absence of unacceptable toxicities and disease progression. The recommended doses from the dose escalation will be further explored.

Drug: HS-20105

Interventions

HS-20105 DRUG

Administered intravenously every 21 days.

HS-20105 Phase Ia (Dose escalation); HS-20105 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:

• Men or women aged more than or equal to (≥) 18 years.
• Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is failed or intolerable.
• Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required). Patients with only brain and/or bone lesions as target lesions will not be included.
• Fresh or archived tumor tissue samples need to be provided (fresh samples are preferred, and tumor tissue samples within 2 years before the first administration can be accepted; the sample type is formalin fixed, paraffin embedded \[FFPE\] tumor tissue block or FFPE slides).
• ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.
• Estimated life expectancy greater than (\>) 12 weeks.
• Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
• Females must have the evidence of non-childbearing potential.
• Sign informed consent form.

You may not qualify if:

• Has received or is currently undergoing the following treatment:
• Previously or current treatment with drugs targeting Trop-2 or other ADC drugs conjugated with HS-9265;
• Received traditional Chinese medicine therapy with anti-tumor indications within 2 weeks prior to the first administration of HS-20105;
• Received cytotoxic chemotherapy drugs or other anti-tumor system therapies (including endocrine therapy, molecular targeted therapy, or biological therapy) within 3 weeks prior to the first administration of HS-20105;
• Received macromolecular anti-tumor drugs or experimental drug therapy within 4 weeks before the first administration of HS-20105;
• Received local radiotherapy within 2 weeks before the first administration of HS-20105; Received more than 30% of bone marrow irradiation or extensive radiation therapy within 4 weeks before the first administration of HS-20105;
• Received major surgery within 4 weeks before the first administration of HS-20105.
• Received strong inhibitors or inducers of CYP3A4, CYP2D6, P-gp or BCRP, or drugs with narrow treatment windows for CYP3A4, CYP2D6, P-gp or BCRP sensitive substrates, have been used.
• Receiving medication that is known to prolong the QT interval or may lead to torsade de pointes.
• Existing abnormal CTCAE ≥ grade 2 resulted from previous treatment.
• History of other malignancy.
• Uncontrolled pleural, ascites or pericardial effusion.
• Known and unstable central nervous system metastases.
• Inadequate bone marrow reserve or serious organ dysfunction.
• Severe, uncontrolled, or active cardiovascular disease.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Central Study Contacts

Binghe Xu, PhD

CONTACT

86-10-87788495; xubinghe@csco.org.cn

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 10, 2023
• First Posted: November 22, 2023
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 22, 2023

Record last verified: 2023-11