Clinical trial NCT06737731: A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Malignant Solid Tumors
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
2. 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;
3. Have at least one measurable tumor lesion per RECIST v1.1;
4. ECOG performance score of 0-1;
5. Life expectancy ≥ 3 months;
6. Adequate bone marrow and organ function.

Exclusion Criteria:

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

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: 12 months.
measure: Maximum administered dose (MAD)
timeFrame: 12 months.
measure: Recommended Phase 2 dose (RP2D)
timeFrame: 12 months.
measure: Incidence and severity of adverse events (AEs)
timeFrame: Approximately 3 years.
measure: Incidence and severity of serious adverse events (SAEs)
timeFrame: Approximately 3 years.
Secondary outcomes:
measure: Time to maximum concentration (Tmax) of SHR-1681
timeFrame: Approximately 3 years.
measure: Maximum concentration (Cmax) of SHR-1681
timeFrame: Approximately 3 years.
measure: Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681
timeFrame: Approximately 3 years.
measure: Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681
timeFrame: Approximately 3 years.
measure: Anti-SHR-1681 antibody (ADA) of SHR-1681
timeFrame: Approximately 3 years.
measure: Overall response rate (ORR)
timeFrame: Approximately 3 years.
measure: Duration of response (DoR)
timeFrame: Approximately 3 years.
measure: Disease control rate (DCR)
timeFrame: Approximately 3 years.
measure: Progression-free survival (PFS)
timeFrame: Approximately 3 years.
measure: Overall survival (OS)
timeFrame: Approximately up to 5 years after the last subject enrolled.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Dongfang Hospital
state: Shanghai
Study officials:
References: