Active — Not RecruitingPhase 1/2

A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer

China157 participantsStarted 2021-04-23

Plain-language summary

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification, or mutation

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Able and willing to provide a written informed consent
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. advanced non-small cell lung cancer with HER2 expression , amplification, or mutation
✓. has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy.
✓. There is at least one measurable lesion according to RECIST V1.1 criteria

Exclusion criteria

✕. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
✕. Has received HER2 antibody drug conjugates,
✕. Central nervous system metastasis or meningeal metastasis with clinical symptoms
✕. Has active infection requiring systemic treatment.

What they're measuring

Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811

Timeframe: From Day 1 to90 days after last dose ，appropriately to 3 years

Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811

Timeframe: From Day 1 to90 days after last dose ，appropriately to 3 years

Phase1: Maximum tolerated dose (MTD)

Timeframe: 12 months

Phase 1: Recommended Phase 2 dose (RP2D)

Timeframe: 12 months

Phase2:ObjectiveResponse Rate (ORR)

Timeframe: Subjects were evaluated on tumor imaging every 6 weeks after treatment initiation and every 12 weeks after 54 weeks, until imaging progression, initiation of new antitumor therapy, loss of follow-up, and death，appropriately to 3 years

Trial details

NCT IDNCT04818333

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06

View on ClinicalTrials.gov More Advanced Non-small Cell Lung Cancer trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Able and willing to provide a written informed consent
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. advanced non-small cell lung cancer with HER2 expression , amplification, or mutation
✓. has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy.
✓. There is at least one measurable lesion according to RECIST V1.1 criteria

Exclusion criteria

✕. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
✕. Has received HER2 antibody drug conjugates,
✕. Central nervous system metastasis or meningeal metastasis with clinical symptoms
✕. Has active infection requiring systemic treatment.

What they're measuring

Phase 1:Incidence of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811

Timeframe: From Day 1 to90 days after last dose ，appropriately to 3 years

Phase 1:Severity of Adverse Events (AEs) by CTCAE v5.0 of SHR-A1811

Timeframe: From Day 1 to90 days after last dose ，appropriately to 3 years

Phase1: Maximum tolerated dose (MTD)

Timeframe: 12 months

Phase 1: Recommended Phase 2 dose (RP2D)

Timeframe: 12 months

Phase2:ObjectiveResponse Rate (ORR)