Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors

NCT ID: NCT05718219

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-29
• Study Completion Date: 2026-12-30

Brief Summary

This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy or with sintilimab in adult subjects with advanced and metastatic solid tumors. The trial starts with a dose escalation and dose expansion part (Part 1) followed by a cohort expansion part (Part 2).

Conditions

Advanced Solid Tumors

Study Design

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

Study Groups

Part 1A ( SIM0348 Monotherapy)

Part 1A (dose escalation and dose expansion) Cohorts of at least 3 participants each will be treated with escalating doses of SIM0348 alone or in combination with Sintilimab . Dose expansion part will be decided based on the findings of dose escalation part. Part 1A was to evaluate single agent SIM0348 once weekly or once every 3 weeks.

Group Type: EXPERIMENTAL

SIM0348

Intervention Type: DRUG

Several dose levels will be evaluated for SIM0348 administered as a single agent . SIM0348 will be given via IV infusion on Day 1, Day 8, Day 15, Day 22 of each cycle (28-day or depending on study cohort and phase) until disease progression or loss of clinical benefit.

Part 1B (SIM0348 + Sintilimab )

Part 1B (dose escalation and dose expansion) Cohorts of at least 3 participants each will be treated with escalating doses of SIM0348 alone or in combination with Sintilimab. Dose expansion part will be decided based on the findings of dose escalation part. In Part 1B, selected dose from Part 1A were evaluated in Part 1B when they were combined with Sintilimab (200mg once every 3 weeks)

Group Type: EXPERIMENTAL

SIM0348 + Sintilimab

Intervention Type: DRUG

Selected doses from Part 1A will be evaluated for SIM0348 when they were combined with Sintilimab (200mg once every 3 weeks).

Part 2A (SIM0348 Monotherapy Cohort Expansion)

Selected doses from Part 1A will be evaluated for SIM0348 administered as a single agent. SIM0348 will be given via IV infusion until disease progression or loss of clinical benefit.

Group Type: EXPERIMENTAL

SIM0348

Intervention Type: DRUG

Several dose levels will be evaluated for SIM0348 administered as a single agent . SIM0348 will be given via IV infusion on Day 1, Day 8, Day 15, Day 22 of each cycle (28-day or depending on study cohort and phase) until disease progression or loss of clinical benefit.

Part 2B (SIM0348 + Sintilimab Cohort Expansion)

Selected doses from Part 1B will be evaluated for SIM0348 when they were combined with Sintilimab (200mg once every 3 weeks)

Group Type: EXPERIMENTAL

SIM0348 + Sintilimab

Intervention Type: DRUG

Selected doses from Part 1A will be evaluated for SIM0348 when they were combined with Sintilimab (200mg once every 3 weeks).

Interventions

SIM0348

Several dose levels will be evaluated for SIM0348 administered as a single agent . SIM0348 will be given via IV infusion on Day 1, Day 8, Day 15, Day 22 of each cycle (28-day or depending on study cohort and phase) until disease progression or loss of clinical benefit.

Intervention Type: DRUG

SIM0348 + Sintilimab

Selected doses from Part 1A will be evaluated for SIM0348 when they were combined with Sintilimab (200mg once every 3 weeks).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults 18 years of age or older
• Must have failed at least one established standard anti-cancer therapies
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy at least 12 weeks
• Adequate hematologic and end organ function
• Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care
• Confirmed availability of representative tumor specimens
• Measurable disease according to RECIST Version 1.1

Exclusion Criteria

• Malignancies other than disease under study within 2 years prior to Day 1 of Cycle 1
• Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
• History of interstitial lung disease, evidence of active pneumonitis (history of radiation pneumonitis in the radiation field [fibrosis] is permitted), and active pneumonia that are considered inappropriate by the investigator
• History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• History of autoimmune disease
• Positive human immunodeficiency virus (HIV) test
• Severe infection within 2 weeks prior to the first dose of study treatment
• Significant cardiovascular disease
• History of allogeneic tissue/solid organ transplant or graft-versus-host disease
• Known clinically significant liver disease

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

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SIM0348-101

Identifier Type: -

Identifier Source: org_study_id