SHR-A1811 for Solid Tumors

No longer recruiting at 42 trial locations

Overseen By Sherry Zhu, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Disqualifiers: Lung diseases, Bleeding tendency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SHR-A1811, an experimental therapy, to determine its safety and effectiveness for people with advanced solid tumors that have a specific protein change known as HER2. The study consists of three parts, each focusing on different aspects such as the right dose and how the body processes the drug. It targets individuals whose cancer has not responded to standard treatments or for whom no standard treatment exists. Ideal participants are those with HER2-expressing tumors who have faced challenges with current treatments and seek new options. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that SHR-A1811 is likely to be safe for humans?

Research has shown that SHR-A1811 is generally safe for people. Studies have found it has a good safety record and is usually well-tolerated. Even patients who have tried many other treatments have managed SHR-A1811 well. Promising evidence suggests it works effectively against tumors, especially those that are HER2 positive or have certain mutations. This indicates that SHR-A1811 has been tested in people with various types of solid tumors and has demonstrated effectiveness without causing many serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SHR-A1811 is unique because it represents a new approach to treating solid tumors, differing from traditional treatments like chemotherapy and radiation. Most current treatments broadly attack both healthy and cancerous cells, but SHR-A1811 is designed to specifically target cancer cells, potentially reducing side effects. Researchers are excited about its mechanism, which involves a novel antibody-drug conjugate that delivers a potent anti-cancer agent directly to the tumor cells. This targeted approach could lead to more effective treatments with fewer adverse reactions.

What evidence suggests that SHR-A1811 might be an effective treatment for solid tumors?

Research has shown that SHR-A1811 holds promise for treating advanced solid tumors, particularly those with HER2 gene alterations. In studies, 59.9% of patients with various solid tumors responded well to SHR-A1811. Specifically, the response rate for patients with HER2-positive breast cancer was even higher at 76.3%. Additionally, patients experienced a median progression-free survival of 8.4 months, during which their cancer did not worsen. These results suggest that SHR-A1811 could be an effective option for patients with certain advanced cancers. Participants in this trial will join different treatment arms, including dose escalation, PK expansion, and indication expansion, to further evaluate SHR-A1811's effectiveness and safety. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that show HER2 expression or mutation, who have tried standard treatments without success or can't tolerate them. Participants must be in good physical condition (ECOG 0-1), have a heart's pumping ability of at least 50%, and proper kidney and liver function. Women must not be pregnant or breastfeeding.

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

LVEF ≥ 50% by either ECHO or MUGA

Has adequate renal and hepatic function

Exclusion Criteria

History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period

Known hereditary or acquired bleeding and thrombotic tendency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of SHR-A1811 to evaluate safety and tolerability

12 weeks

PK Expansion

Participants are monitored for pharmacokinetics and immunogenicity of SHR-A1811

1 year

Indication Expansion

Participants are evaluated for anti-tumor efficacy using RECIST 1.1 criteria

Up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• SHR-A1811

Trial Overview The study tests SHR-A1811, focusing on its safety, how the body processes it, if it causes any immune reactions, and whether it can shrink tumors. It's an early-phase trial where all participants receive SHR-A1811 to see how well it works against different types of solid tumors.

How Is the Trial Designed?

Group I: Part 3 Indication expansion Experimental Treatment 1 Intervention

Group II: Part 2 PK expansion Experimental Treatment 1 Intervention

Group III: Part 1 Dose escalation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Jiangsu HengRui Medicine Co., Ltd.

Lead Sponsor

Trials

663

Recruited

102,000+

Founded

1970

Headquarters

Lianyungang, China

Known For

Oncology Innovations

Top Products

Camrelizumab, Rivoceranib (Apatinib)

Atridia Pty Ltd.

Industry Sponsor

Trials

30

Recruited

1,200+

Published Research Related to This Trial

In a phase I trial of SHR7390 monotherapy involving 16 patients, the maximum tolerated dose (MTD) was determined to be 0.75 mg, with 25% of patients experiencing grade ≥3 treatment-related adverse events, but no objective responses were achieved.

In a combination trial with SHR7390 and camrelizumab involving 22 patients with treatment-refractory colorectal cancer, the combination showed a manageable safety profile with 22.7% of patients achieving a partial response, indicating preliminary clinical activity regardless of tumor genetic status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Clinical Activity of SHR7390 Monotherapy or Combined With Camrelizumab for Advanced Solid Tumor: Results From Two Phase I Trials. Wei, XL., Zhang, Y., Zhao, HY., et al.[2023]

Citations

1. nature.com nature.com/articles/s41392-024-01897-y

SHR-A1811 (antibody-drug conjugate) in advanced HER2- ... The median progression-free survival was 8.4 months (95% CI 7.1–15.0). SHR-A1811 demonstrated favourable safety and clinically meaningful ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38900984/

Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a ... SHR-A1811 led to objective responses in 59.9% (184/307) of all patients, 76.3% (90/118) of HER2-positive breast cancer, 60.4% (55/91) of HER2 ...

3. aacrjournals.org aacrjournals.org/clincancerres/article/31/12_Supplement/PS8-08/753552/Abstract-PS8-08-Efficacy-and-safety-of-SHR-A1811

Abstract PS8-08: Efficacy and safety of SHR-A1811, an anti ... This updated analysis reaffirms the manageable safety profile and promising efficacy of SHR-A1811 in heavily pretreated multiple solid tumors with HER2 ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.1103

SHR-A1811 plus adebrelimab in unresectable or ... Among efficacy evaluable TNBC pts, the overall ORR was 66.7% (26/39) (Table). ORR was 77.8% (21/27) in the PD-L1-positive subgroup. The 6-month ...

5. onclive.com onclive.com/view/shr-a1811-maintains-efficacy-safety-in-pretreated-her2-expressing--mutated-breast-cancer-other-solid-tumors

SHR-A1811 Maintains Efficacy, Safety in Pretreated HER2- ... SHR-A1811 demonstrated high objective response rates in HER2-positive breast cancer, with a 79.1% ORR and a median PFS of 20 months. The study ...

6. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.23.02044

Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a ... SHR-A1811 exhibited acceptable tolerability, promising antitumor activity, and a favorable pharmacokinetic profile in heavily pretreated advanced solid tumors.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04446260

NCT04446260 | A Study of SHR-A1811 in Subjects With ... This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy ...