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Malignant Solid TumorsPhase 2NCT07028281

A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors

A Phase 2 study testing SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin in people with Malignant Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals 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
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Trial summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection combined with other antitumor drugs in patients with malignant solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Solid Tumors
What is being tested?
SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
8 Jul 2025to Dec 2028
Phase
Phase 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has provided informed consent prior to initiation of any study-procedures
  • Age from 18 to 75 years old at the time of signing the informed consent
  • Histologically or cytologically confirmed solid tumors
  • At least one measurable lesion was identified per RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Has a life expectancy of at least 3 months.
  • Adequate organ function
  • Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 8 months after the last dose of the trial drug

Who cannot join

  • Subjects with active central nervous system (CNS) metastasis.
  • Subjects with a history of malignant tumors within 5 years prior to the first dose
  • Subjects with uncontrolled cancer pain.
  • Subjects with severe cardiovascular disease.
  • Subjects with clinically significant hemorrhage
  • Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion
Show all 17Show fewer
  • Subjects highly suspected of interstitial lung disease
  • Subjects with serious infection within 4 weeks prior to the first dose
  • Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or hepatitis C virus infection.
  • The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1
  • Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
  • Subjects who received major surgery within 4 weeks prior to the first dose
  • Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
  • Female subjects who were pregnant, lactating, or planned to become pregnant during the study period
  • Known allergic to any component of investigational drugs
  • Alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection.
  • Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,

Trial locations and contacts

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

Wei Hou contact

0518-82342973

wei.hou@hengrui.com

China1 site, 1 recruiting

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Jinming Yu

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-label, Phase II Clinical Study of SHR-4849 Injection Combined With Other Antineoplastic Drugs in Patients With Malignant Solid Tumors

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection combined with other antitumor drugs in patients with malignant solid tumors.

Being tested
SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin

What participants receive

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

  • SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatinDrug

    SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin

Study groups in NCT07028281
Study groupRoleWhat they receive
Treatment group AExperimentalNot described
Receives: Drug: SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin

What is being measured

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

  1. DLT：the incidence of events associated with the investigational drug determined by the investigator during the observation period(The first stage)

    Measured: up to 21 days

  2. Incidence and severity of AE/SAE：According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The first stage)

    Measured: up to 24 months

  3. Objective Response Rate (ORR) as Assessed by investigators(The second stage)

    Measured: up to 24 months

Secondary outcomes (10)

  1. ORR(The first stage)

    Objective Response Rate (ORR) as Assessed by investigators. The proportion of subjects whose best response was PR or CR according to RECIST1.1

    Measured: up to 24 months

  2. DoR(The first stage)

    Duration of Response (DOR) as Assessed by investigators according to RECIST1.1, Defined as the period of time from the first documented tumor response to the first documented objective progression or death of any cause.

    Measured: up to 24 months

  3. DCR(The first stage)

    Disease Control Rate(DCR) as Assessed by investigators. the proportion of subjects whose best response was PR or CR or SD according to RECIST1.1

    Measured: up to 24 months

  4. PFS(The first stage)

    Progression-free Survival (PFS) as Assessed by investigators according to RECIST1.1. Defined as the time from the initiation of the first medication to tumor progression or death from any cause (whichever comes first)

    Measured: up to 24 months

  5. OS(The first stage)

    Overall Survival . Defined as the time from the initiation of the first medication to death from any cause.

    Measured: up to 30 months

  6. DoR(The second stage)

    Duration of Response (DOR) as Assessed by investigators according to RECIST1.1, Defined as the period of time from the first documented tumor response to the first documented objective progression or death of any cause.

    Measured: up to 24 months

  7. DCR(The second stage)

    Disease Control Rate(DCR) as Assessed by investigators. the proportion of subjects whose best response was PR or CR or SD according to RECIST1.1

    Measured: up to 24 months

  8. PFS(The second stage)

    Progression-free Survival (PFS) as Assessed by investigators according to RECIST1.1. Defined as the time from the initiation of the first medication to tumor progression or death from any cause (whichever comes first)

    Measured: up to 24 months

  9. OS(The second stage)

    Overall Survival . Defined as the time from the initiation of the first medication to death from any cause.

    Measured: up to 30 months

  10. Incidence and severity of AE/SAE：According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The second stage)

    Measured: up to 24 months

Timeline

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

  1. First posted19 Jun 2025
  2. Study start8 Jul 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07028281
Sponsor's protocol ID
SHR-4849-201
Status last verified
Jun 2025
First submitted
11 Jun 2025
Last updated
3 Mar 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 2 study testing SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin in people with Malignant Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals 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 8 inclusion and 17 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 3 Mar 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 phase mean?

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 Wei Hou (0518-82342973, wei.hou@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT：the incidence of events associated with the investigational drug determined by the investigator during the observation period(The first stage) (time frame: up to 21 days). 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 NCT07028281.

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 3 Mar 2026.

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