AzTrials
AzTrials

Advanced Solid TumorsPhase 1/2NCT06417554

A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors

A Phase 1/2 study testing SHR-A2102, SHR-A2102 ; Adebrelimab injection and SHR-A2102 + Disitamab Vedotin For Injection in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with or without Antitumor Therapy in Advanced Solid Tumors. To explore the reasonable dosage of SHR-A2102 for Advanced Solid Tumors. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SHR-A2102, SHR-A2102 ; Adebrelimab injection and SHR-A2102 + Disitamab Vedotin For Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
27 May 2024to 31 Dec 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements；
  • The age of signing the informed consent is above 18 years old, regardless of gender; for the SHR-A2102 combined with Disitamab Vedotin cohort, the maximum upper limit was 80 years old
  • The ECOG score is 0 or 1；
  • Expected survival ≥12 weeks
  • Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, stage Ib subjects who have failed standard treatment; Stage II subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors without systemic antitumor therapy；
  • Provide archived or fresh tumor tissue；
Show all 9Show fewer
  • At least one measurable lesion according to RECIST v1.1 criteria；
  • Good level of organ function；
  • Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.

Who cannot join

  • Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases；
  • Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors; Stage II was previously treated with PD-1/PD-L1 inhibitors；For the SHR-A2102 combined with Disitamab Vedotin cohort, those who have previously received Disitamab Vedotin treatment or antibody-drug conjugates containing topoisomerase I inhibitors
  • Systemic antitumor therapy was received 4 weeks before the start of the study；
  • Palliative radiotherapy was completed within 14 days before the first dose; Chest radiotherapy >30 Gy within 6 months prior to initial administration；
  • Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria；
  • Systemic immunosuppressive therapy was administered within 14 days prior to the first study；
Show all 25Show fewer
  • Subjects with known or suspected interstitial pneumonia；
  • ≥ grade 3 immune-related adverse events occurred during previous treatment with immune checkpoint inhibitors were not eligible to be enrolled in the cohort of SHR-A2102 combined with SHR-1316 ；
  • The presence of any active, known, or suspected autoimmune disease；
  • Moderate or severe ascites with clinical symptoms, uncontrolled or moderate or above pleural effusion and pericardial effusion；
  • The presence of clinical cardiac symptoms or diseases that are not well controlled；
  • Any other malignancy diagnosed within the previous 5 years；
  • Subjects who had a severe infection within 28 days prior to the first dose；
  • Active hepatitis B or active hepatitis C；
  • Patients with active tuberculosis infection within 1 year prior to enrollment, or with a history of active tuberculosis infection more than 1 year prior but without formal treatment；
  • History of immune deficiency；
  • Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study period；
  • Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter；
  • Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing; Presence of non-healing wounds or untreated fractures；
  • Severe allergic reactions are known to occur in individuals allergic to any component of SHR-A2102, SHR-1316, Disitamab Vedotin or other monoclonal antibody/fusion protein drugs；
  • Female subjects who are pregnant or plan to become pregnant during the study period；
  • The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention；
  • In the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate；
  • Severe dry eye syndrome, active keratitis, corneal ulcers, and other conditions that the researchers have assessed may increase the risk of corneal diseases and are not suitable for participation in this study；
  • ≥ grade 2 peripheral neuropathy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chi Zhang contact

+8618456513908

chi.zhang@hengrui.com

China1 site, 1 recruiting

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jun Guo

    Recruiting

Other trials in China

About this study

Official title: A Phase IB /II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With or Without Antitumor Therapy in Subjects With Advanced Solid Tumors

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with or without Antitumor Therapy in Advanced Solid Tumors. To explore the reasonable dosage of SHR-A2102 for Advanced Solid Tumors.

Being tested
SHR-A2102, SHR-A2102 ; Adebrelimab injection, SHR-A2102 + Disitamab Vedotin For Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-A2102Drug

    SHR-A2102

  • SHR-A2102 ; Adebrelimab injectionDrug

    SHR-A2102 + Adebrelimab injection

  • SHR-A2102 + Disitamab Vedotin For InjectionDrug

    SHR-A2102 + Disitamab Vedotin For Injection

Study groups in NCT06417554
Study groupRoleWhat they receive
Treatment group A: SHR-A2102 + Adebrelimab injectionExperimentalNot described
Receives: Drug: SHR-A2102 ; Adebrelimab injection
Treatment group B: SHR-A2102ExperimentalNot described
Receives: Drug: SHR-A2102
Treatment group C: SHR-A2102 + Disitamab Vedotin For InjectionExperimentalNot described
Receives: Drug: SHR-A2102 + Disitamab Vedotin For Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RP2D

    Measured: through phase IB completion, an average of 1 years

  2. Incidence and severity of AE；

    Measured: from Day1 to 90 days after last dose

  3. ORR

    Measured: 18 months after the last subject was enrolled in the group

Secondary outcomes (8)

  1. DCR(Investigator evaluation)

    Measured: 18 months after the last subject was enrolled in the group

  2. DoR(Investigator evaluation)

    Measured: 18 months after the last subject was enrolled in the group

  3. PFS(Investigator evaluation)

    Measured: 18 months after the last subject was enrolled in the group

  4. OS(Investigator evaluation)

    Measured: 18 months after the last subject was enrolled in the group

  5. SHR-A2102 and free toxin PK

    Measured: through study completion, an average of 2 years

  6. SHR-1316 PK

    Measured: through study completion, an average of 2 years

  7. SHR-A2102 Immunogenicity

    Measured: through study completion, an average of 2 years

  8. SHR 1316 Immunogenicity

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start27 May 2024
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06417554
Sponsor's protocol ID
SHR-A2102-201
Status last verified
Jul 2026
First submitted
26 Apr 2024
Last updated
24 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-A2102, SHR-A2102 ; Adebrelimab injection and SHR-A2102 + Disitamab Vedotin For Injection in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chi Zhang (+8618456513908, chi.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D (time frame: through phase IB completion, an average of 1 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06417554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in