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Recruiting NCT06643754

A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors

Phase I / Phase II Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-3276.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-3276 Injection in Patients With Advanced Malignant Tumors

Overview

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients with advanced solid tumors.

Interventions

  • Drug SHR-3276
    Dose Escalation: SHR-3276 will be administered intravenously. 4 dose levels are preset. Dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. Indication Expansion: Indications will be selected to evaluate preliminary efficacy.

Primary outcome measures

  • Incidence and severity of adverse events [Time frame: up to 3 years]
  • MTD [Time frame: up to 6 months]
  • RP2D [Time frame: up to 1 year]
Secondary outcome measures (9)
  • Time to maximum concentration (Tmax) [Time frame: up to 3 years]
  • Maximum concentration (Cmax) [Time frame: up to 3 years]
  • Receptor Occupancy（OR） of SHR-3276 [Time frame: up to 3 years]
  • Anti-drug antibody (ADA) of SHR-3276 [Time frame: up to 3 years]
  • Objective response rate (ORR) [Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years]
  • Duration of response (DoR) [Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years]
  • Disease control rate (DCR) [Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years]
  • Progression free survival（PFS） [Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years]
  • Overall survival (OS) [Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years]

Eligibility criteria

Inclusion criteria

  • Able and willing to sign a written informed consent；
  • Age 18-70 years old (including both ends), both male and female；
  • Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan；
  • Existence of measurable lesions；
  • ECOG score: 0-1；
  • Expected survival time ≥ 12 weeks；
  • The functional level of the major organs must meet the requirements；
  • Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating.

Exclusion criteria

  • Central nervous system metastasis or meningeal metastasis with clinical symptoms;
  • Spinal cord compression that has not been treated radically by surgery and/or radiotherapy；
  • Patients with uncontrolled tumor-related pain as judged by the investigator
  • A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator；
  • Systemic antitumor therapy was administered within 28 days prior to treatment in the first study；
  • Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, or elective surgery was expected during the trial period；
  • Serious drug-related adverse reactions during previous immune checkpoint inhibitor therapy；
  • Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1；
  • Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment；
  • Systemic immunosuppressive therapy was administered within 14 days prior to the first study
  • Arterial/venous thrombosis events occurred within 3 months prior to initial administration
  • Patients with clinical significant lung disease;
  • Patients with history of autoimmune diseases;
  • The first study studied any other malignancy within 5 years prior to medication
  • A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients；
  • Have a history of immune deficiency or organ transplantation；
  • Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of PLA Army Medical University — Chongqing

Identifiers

NCT: NCT06643754 · SHR-3276-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗