Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Escalating Doses of SIM0348 as a Single Agent in Advanced Solid Tumors

Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05718219
Collaborator
(none)
68
2
33

Study Details

Study Description

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 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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I, First-in-Human, Open-Label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Subjects With Advanced Solid Tumors
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1 (dose escalation and dose expansion)

Cohorts of at least 3 participants each will be treated with escalating doses of SIM0348. Dose expansion part will be decided based on the findings of dose escalation part.

Drug: 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.

Experimental: Part 2 (cohort expansion)

Participants will be treated with SIM0348 at a recommended dose (RD) in the study.

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. Dose-limiting toxicity (DLT) [DLT evaluation window was from Baseline to the end of Cycle 1 (up to 28 days)]

    Part 1

  2. Objective response rate (ORR) assessed by Investigator per RECIST v.1.1 [up to approximately 2 years]

    Part 2: To evaluate the anti-tumor activity of SIM0348

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05718219
Other Study ID Numbers:
  • SIM0348-101
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023