A Phase I Clinical Study of HS-20117 in Participants With Advanced Solid Tumors

NCT05940116 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-20117-101
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

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, pharmacokinetics (PK), and preliminary efficacy of HS-20117 as a monotherapy for participants with advanced solid tumors.

Conditions

Non-Small Cell Lung Cancer; Solid Tumor

Keywords

Non-Small Cell Lung Cancer; Solid Tumor; HS-20117; Epidermal Growth Factor Receptor; c-Mesenchymal-Epithelial Transition; Bispecific Antibody; EGFR exon 20 insertion

Outcome Measures

Primary Outcomes (3)

• [Phase 1a] Maximum tolerated dose (MTD) of HS-20117

  MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT.

  Cycle 1 (28 days)

• [Phase 1a] Maximum applicable dose (MAD) of HS-20117

  MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.

  Cycle 1 (28 days)

• [Phase 1b] Efficacy of HS-20117: Objective response rate (ORR)

  ORR is defined as the percentage of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1

  From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years

Secondary Outcomes (12)

• [phase 1a and 1b] Incidence and severity of treatment-emergent adverse events

  From the date of first dose until 90 days after the final dose. A cycle is 28 days

• [phase 1a and 1b] PK parameters: Maximum serum concentration (Cmax) of HS-20117

  From the date of first dose until 30 days after the final dose. A cycle is 28 days.

• [phase 1a and 1b] PK parameters: Trough serum concentration (Ctrough) of HS-20117

  From the date of first dose until 30 days after the final dose. A cycle is 28 days.

• [phase 1a and 1b] PK parameters: Time to reach maximum observed serum concentration (Tmax) of HS-20117

  From the date of first dose until 30 days after the final dose. A cycle is 28 days

• [phase 1a] PK parameters: Area under the curve from time Zero to end of dosing interval (AUCtau) of HS-20117

  From the date of first dose until 30 days after the final dose. A cycle is 28 days.

Study Arms (1)

HS-20117

EXPERIMENTAL

Participants will receive IV infusion of HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days)

Drug: HS-20117

Interventions

HS-20117 DRUG

Phase Ia: patients will receive HS-20117 starting at 400 mg, and subsequent cohorts will test escalating doses, if tolerated, until a maximum tolerated dose (MTD) or maximum applicable dose (MAD) is defined. Phase Ib: patients will receive HS-20117 at MED or MAD

Also known as: PM1080

HS-20117

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18 - 75 years (inclusive).
• For the phase Ia study: Participants with locally advanced or metastatic NSCLC (stage IIIB/IIIC/IV) with EGFR-activating mutations who have progressed after or are intolerant to or not available to standard of care (SoC).
• For the phase Ib study:
• Cohort A: Participants with locally advanced or metastatic NSCLC (stage IIIB/IIIC/IV) with EGFR exon 20ins mutations who have progressed after prior platinum-based chemotherapy or are intolerant to platinum-based chemotherapy.
• Cohort B: Participants with other advanced solid tumors who have progressed after prior SoC or are intolerant to SoC.
• Agree to provide fresh or archival tumor tissue.
• At least one target lesion per the RECIST v1.1.
• ECOG performance status of 0-1.
• Minimum life expectancy \> 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.
• Have signed Informed Consent Form.

You may not qualify if:

• Received or are receiving the following treatments:
• For the phase Ib study Cohort A: Previous or current treatment with EGFR exon 20ins targeted therapy.
• Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of HS-20117.
• Cytotoxic chemotherapies, investigational drugs or other systematic anti-tumor therapies within 3 weeks prior to the first dose of HS-20117.
• Antibodies within 4 weeks prior to the first dose of HS-20117.
• 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.
• Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
• Major surgery within 4 weeks prior to the first dose of HS-20117.
• Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
• History of other primary malignancies.
• Untreated, or active central nervous system metastases.
• Inadequate bone marrow reserve or organ functions.
• Severe, uncontrolled or active cardiovascular disorders.
• Severe or uncontrolled systemic diseases.
• Severe bleeding symptoms or bleeding tendencies within 1 month prior to the first dose of HS-20117.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300181, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dingzhi Huang

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Zhou

CONTACT

+86 18013002767; zhoup7@hspharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 11, 2023
• Study Start: July 20, 2023
• Primary Completion: July 30, 2025
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 12, 2023

Record last verified: 2023-07

Locations

CN (1)