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

NCT05263479 | Recruiting Phase 1

• 1 other identifier: HS-20089-101
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Keywords

HS-20089; ADC; B7-H4; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of HS-20089

  To determine the MTD for further evaluation of IV administration of HS-20089 in subjects with advanced solid tumors.

  3 weeks after initiation of treatment

Secondary Outcomes (9)

• Incidence and severity of treatment-emergent adverse events

  Baseline through study completion(90 days after last dose)

• Observed maximum plasma concentration (Cmax) after single dose of HS-20089

  From pre-dose to 120 hours after single dose on Day 1

• Observed maximum plasma concentration (Cmax ss) after multiple dose of HS-20089

  From pre-dose to 24 hours after the dose on Day 1 of the 21-Day cycle of therapy

• Apparent terminal half-life (t1/2) after single dose of HS-20089

  From pre-dose to 120 hours after single dose on Day 1

• Area under plasma concentration versus time curve from zero to the 24-hour sampling time (AUC0-24) after single dose of HS-20089

  From pre-dose to 24 hours after single dose on Day 1

Study Arms (2)

HS-20089 (Phase Ia：Dose escalation )

EXPERIMENTAL

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

Drug: HS-20089 (Phase Ia：Dose escalation )

HS-20089 (Phase Ib: Dose expansion)

EXPERIMENTAL

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

Drug: HS-20089 (Phase Ib: Dose expansion)

Interventions

HS-20089 (Phase Ia：Dose escalation ) 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 Ia：Dose escalation )

HS-20089 (Phase Ib: Dose expansion) 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.

HS-20089 (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 invalid, unavailable 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)
• ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
• Estimated life expectancy greater than (\>) 12 weeks
• 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
• Sign Informed Consent Form

You may not qualify if:

• Treatment with any of the following:
• Previous or current treatment with drugs targeting B7-H4
• Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug
• 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.
• Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
• Known and untreated, or active central nervous system metastases.
• Existing abnormal CTCAE≥grade 2 resulted from previous treatment
• History of other malignancy
• Inadequate bone marrow reserve or organ function
• Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV
• History of hypersensitivity to any active or inactive ingredient of HS-20089.
• 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.
• Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.

Sponsors & Collaborators

• Shanghai Hansoh Biomedical Co., Ltd: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Officials

• Jiong Wu, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong Wu, PhD

CONTACT

13601637369; wujiong1122@vip.sina.com

Jian Zhang, PhD

CONTACT

18017312991; Syner2000@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: October 29, 2021
• First Posted: March 2, 2022
• Study Start: January 5, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)