A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer

NCT05482568 | Recruiting Phase 1

• 1 other identifier: SHR-A1811-II-203
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 2

Brief Summary

This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.

Conditions

Advanced Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• DLT(Phase I (dose exploration phase) main study endpoint)

  21 days after the first administration of each subject

• AE(Phase I (dose exploration phase) main study endpoint)

  Two years after the last subject was enrolled in the group

• Incidence and severity of serious adverse events (SAE)(Phase I (dose exploration phase) main study endpoint)

  Two years after the last subject was enrolled in the group

• Objective response rate(The main end points of the second stage (efficacy expansion stage))

  Two years after the last subject was enrolled in the group

Secondary Outcomes (25)

• Toxin binding antibody to shr-a1811（Phase I secondary endpoint）

  Two years after the last subject was enrolled in the group

• Total antibody to shr-a1811（Phase I secondary endpoint）

  Two years after the last subject was enrolled in the group

• Plasma concentration of free toxin shr169265（Phase I secondary endpoint）

  Two years after the last subject was enrolled in the group

• Plasma concentration of pyrroltinib（Phase I secondary endpoint）

  Two years after the last subject was enrolled in the group

• Plasma concentration of SHR-1316（Phase I secondary endpoint）

  Two years after the last subject was enrolled in the group

Study Arms (1)

SHR-A1811 combined with Pyrotinib/SHR-A1811 combined with SHR-1316

EXPERIMENTAL

Drug: SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316

Interventions

SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316 DRUG

Drug: SHR-A1811 \& Pyrotinib SHR-A1811： intravenous Pyrotinib：oral Drug: SHR-A1811 \& SHR-1316 SHR-A1811： intravenous SHR-1316： intravenous

SHR-A1811 combined with Pyrotinib/SHR-A1811 combined with SHR-1316

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
• When signing the informed consent, the age is 18-75 years old (including both ends), and there is no gender limitation
• The ECOG score is 0 or 1
• The expected survival is ≥12 weeks
• Subjects with advanced or metastatic non-small cell lung cancer
• Formalin fixed, paraffin-embedded tumor tissue blocks or sections of unstained tumor specimens are provided
• Subjects who have failed prior standard care or are intolerant to standard care
• There is at least one measurable lesion
• Vital organs are functioning well
• Heart function is good
• Agree to birth control

You may not qualify if:

• There are untreated or active central nervous system (CNS) tumor metastases
• Pleural, ascites, or pericardial effusion requiring intervention occurred within 7 days prior to initial administration
• Systemic antitumor therapy was performed 4 weeks prior to study initiation
• Prior treatment with antibody-conjugated drugs
• Received \>30 Gy chest radiation within 6 months prior to initial administration
• Palliative radiotherapy was completed within 7 days prior to initial administration
• Failure to recover from toxicity and/or complications of previous interventions to nCI-CTCAE ≤1
• The half-life of CYP3A4 suppressor, moderate inhibitor or strong inducer or moderate inducer is less than 3 or less than 14 days from the date of first drug use, and the shorter is selected
• Received systemic immunosuppressant therapy within 14 days prior to the first study
• Subjects with known or suspected interstitial pneumonia
• In the first study, failure to swallow, chronic diarrhea, gastroenteritis, intestinal obstruction, gastrointestinal perforation, postgastrectomy, or colitis, or other medical conditions or special conditions affecting drug administration and absorption occurred within 28 days prior to administration
• Presence of any active, known or suspected autoimmune disease
• Have poorly controlled or severe cardiovascular disease
• Previous or concurrent malignancy
• Subjects who developed a severe infection within 28 days prior to the first dose

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Shanghai Chest hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Central Study Contacts

Suqiang Yu

CONTACT

+0518-82342973; suqiang.yu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open, multicenter, dose-increasing/investigational Phase IB/II clinical trial

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 1, 2022
• Study Start: September 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (2)