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Recruiting NCT06737731

A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors

Phase I / Phase II Interventional Malignant 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-1681.
Who it may be relevant to
Registry conditions: Malignant Solid Tumors. Basic parameters: 18 years — 75 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, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1681 for Injection in Patients With Malignant Solid Tumors

Overview

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.

Interventions

  • Drug SHR-1681
    SHR-1681 for Injection will be administrated per dose level in which the patients are assigned.

Primary outcome measures

  • Maximum tolerated dose (MTD) [Time frame: 12 months.]
  • Maximum administered dose (MAD) [Time frame: 12 months.]
  • Recommended Phase 2 dose (RP2D) [Time frame: 12 months.]
  • Incidence and severity of adverse events (AEs) [Time frame: Approximately 3 years.]
  • Incidence and severity of serious adverse events (SAEs) [Time frame: Approximately 3 years.]
Secondary outcome measures (10)
  • Time to maximum concentration (Tmax) of SHR-1681 [Time frame: Approximately 3 years.]
  • Maximum concentration (Cmax) of SHR-1681 [Time frame: Approximately 3 years.]
  • Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681 [Time frame: Approximately 3 years.]
  • Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681 [Time frame: Approximately 3 years.]
  • Anti-SHR-1681 antibody (ADA) of SHR-1681 [Time frame: Approximately 3 years.]
  • Overall response rate (ORR) [Time frame: Approximately 3 years.]
  • Duration of response (DoR) [Time frame: Approximately 3 years.]
  • Disease control rate (DCR) [Time frame: Approximately 3 years.]
  • Progression-free survival (PFS) [Time frame: Approximately 3 years.]
  • Overall survival (OS) [Time frame: Approximately up to 5 years after the last subject enrolled.]

Eligibility criteria

Inclusion criteria

  • Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
  • Subjects with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
  • Have at least one measurable tumor lesion per RECIST v1.1;
  • ECOG performance score of 0-1;
  • Life expectancy ≥ 3 months;
  • Adequate bone marrow and organ function.

Exclusion criteria

  • Subjects with active central nervous system metastases or meningeal metastases;
  • History of serious cardiovascular and cerebrovascular diseases;
  • Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
  • Severe infection within 4 weeks prior to the first dose;
  • Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
  • Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

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
  • Shanghai Dongfang Hospital — Shanghai

Identifiers

NCT: NCT06737731 · SHR-1681-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗