A Study of HS-20089 in Patients With Advanced Solid Tumors

NCT ID: NCT05263479

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2026-12-31

Brief Summary

HS-20089 is a novel DAR-6 antibody-drug conjugate （ADC） targeting B7-H4. In preclinical studies, it inhibited tumor cell growth expressing B7-H4 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-20089 in Patients With Advanced Solid Tumors.

Detailed Description

This is a Phase 1a/1b open-label, multicenter study with dose escalation and dose expansion cohorts to evaluate the safety, tolerability, PK and preliminary efficacy of HS-20089 in patients with advanced solid tumors.

The Dose Escalation will include an initial accelerated titration design followed by a Bayesian optimal interval (BOIN) design. Enrollment into Dose Expansion will begin after identification of the MTD and/or MAD in Phase 1a. In Phase 1b, preliminary efficacy will be evaluated in planned expansion cohorts that include patients with specific tumor types that are B7-H4+ advanced solid tumors.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HS-20089 (Phase Ia：Dose escalation )

HS-20089 for IV infusion of various dose strengths administered in 21 day dosing cycles.

Group Type: EXPERIMENTAL

HS-20089 (Phase Ia：Dose escalation )

Intervention Type: DRUG

Participants will receive HS-20089 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-20089 (Phase Ib: Dose expansion)

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

Group Type: EXPERIMENTAL

HS-20089 (Phase Ib: Dose expansion)

Intervention Type: DRUG

IV administration of HS-20089 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Interventions

HS-20089 (Phase Ia：Dose escalation )

Participants will receive HS-20089 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.

Intervention Type: DRUG

HS-20089 (Phase Ib: Dose expansion)

IV administration of HS-20089 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men or women aged more than or equal to (≥) 18 years

2. Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable

3. 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)

4. ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks

5. Estimated life expectancy greater than (>) 12 weeks

6. Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential

7. Sign Informed Consent Form

Exclusion Criteria

1. Treatment with any of the following:

1. Previous or current treatment with drugs targeting B7-H4

2. Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug

3. Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.

4. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.

5. Known and untreated, or active central nervous system metastases.

2. Existing abnormal CTCAE≥grade 2 resulted from previous treatment

3. History of other malignancy

4. Inadequate bone marrow reserve or organ function

5. Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV

6. History of hypersensitivity to any active or inactive ingredient of HS-20089.

7. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.

8. Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Hansoh Biomedical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiong Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiong Wu, PhD

Role: CONTACT

wujiong1122@vip.sina.com

13601637369

Jian Zhang, PhD

Role: CONTACT

Syner2000@163.com

18017312991

Facility Contacts

Jiong Wu, PhD

Role: primary

wujiong1122@vip.sina.com

13601637369

Jian Zhang, PhD

Role: backup

Syner2000@163.com

18017312991

Other Identifiers

HS-20089-101

Identifier Type: -

Identifier Source: org_study_id