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Unresectable Locally Advanced or Metastatic Solid TumorsPhase 1/2NCT06974812

IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 study testing IBI3014 in people with Unresectable Locally Advanced or Metastatic Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 3 sites 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

This is a phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3014 in participants with unresectable locally advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IBI3014
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
3 sitesChina
Study dates
18 Apr 2025to 30 Jun 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Participants with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
  • 2.Male or female participants ≥ 18 years old;
  • 3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  • 4.Anticipated life expectancy of ≥ 12 weeks;
  • 5.Participants, both male and female, who are either not of childbearing potential or who agree to use at least one highly effective method of contraception during the study (begin from screening or within 2 weeks prior to the first dose, whichever comes first, and continue until 6 months after the last dose of study drug).
  • 6.Adequate bone marrow and organ function:
  • 7.Has at least 1 measurable lesion per RECIST v1.1(at least 1 evaluable lesion for dose participants in dose escalation part);
  • 8.Not a candidate for curable surgical resection or radical chemoradiation;

Who cannot join

  • 1.Drugs and other treatments to be excluded;
  • 2.Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to Investigators' opinion) prior to first administration of the study drug;
  • 3.Prior use of Camptothecin-Derived agents (e.g., irinotecan, topotecan) or immune checkpoint inhibitor and documented adverse reaction which is severe and influence the safety assessment of participants.
  • 4.Allergic or hypersensitive to other monoclonal antibodies and/or Camptothecin Derivative based therapy, or any ingredients of IBI3014;
  • 5.Known symptomatic central nervous system (CNS) metastases. The following conditions could be considered enrollment: Participants with asymptomatic CNS metastases (which means no neural system syndromes, no need of corticosteroids treatment and diameter of metastases ≤ 1.5cm) or confirmed stable status according to Investigators' opinion after treatment, No midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord metastasis; and stable status for at least 4 weeks without new or enlarged metastases definitively confirmed by clinical evidence, and withdrawal of corticosteroids or anticonvulsant for at least 2 weeks prior to the first administration of study drug;
  • 6.History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases (e.g. Interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease such as pulmonary fibrosis, severe radiation pneumonitis and acute lung injury) or who are suspected to have these diseases by imaging at screening period;
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  • 7.Participants with a clinically significant (CS) cardiovascular disease or condition;
  • 8.Participants with a significant gastrointestinal disease or condition,
  • 9.Participants with biliary obstruction. Unless the blockage is treated locally, such as endoscopic stenting or percutaneous liver puncture and drainage, the total bilirubin is reduced below 1.5 times ULN;
  • 10.Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
  • 11.Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis;
  • 12.Significant malnutrition, such as the need for intravenous fluids; Malnutrition corrected for more than 4 weeks prior to the first administration of study drug is allowed;
  • 13.Tumor invasion of surrounding important structures (such as mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal/respiratory fistula;
  • 14.Uncontrolled or clinically significant infections
  • 15.History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;
  • 16.Had a history of organ transplantation, allogeneic bone marrow transplantation or hematopoietic stem cell transplantation;
  • 17.Other uncontrolled active disease or acute or chronic diseases or abnormal laboratory test that may: increase risk of study participation or study drug administration, interfere with the interpretation of study results, and, disqualify the participant for study participation in the Investigator's judgment;
  • 18.History of other primary malignant tumors;
  • 19.Women who are considered pregnant or are lactating;
  • 20.Under neurological, psychiatric disorder or social condition that affects compliance with study requirements, significantly increases the risk of adverse events, or affects participants' ability to provide written informed consent;

Trial locations and contacts

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

Wei Zhang contact

15005136320

wei.zhang02@innoventbio.com

China3 sites, 3 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    yaqian Han, 0731-89762021, hanyaqian@hnca.org.cn

    yaqian Han

    Recruiting

  • Fujian cancer hospital

    Fuzhou, Fujian, 350014

    Yu Chen, 0591-6275 2224, 13859089836@139.com

    Yu Chen

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Shengxiang Ren, 021-65115006-2403, harry_ren@126.com

    Shengxiang Ren

    Recruiting

Other trials in China

About this study

Official title: A Phase 1/2 Study of IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

This is a phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3014 in participants with unresectable locally advanced or metastatic solid tumors.

Being tested
IBI3014

What participants receive

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

  • IBI3014Drug

    12 mg/kg D1 IV Q3W

  • IBI3014Drug

    6 mg/kg D1 IV Q3W

  • IBI3014Drug

    1 mg/kg D1 IV Q3W

  • IBI3014Drug

    15 mg/kg D1 IV Q3W

  • IBI3014Drug

    9 mg/kg D1 IV Q3W

  • IBI3014Drug

    3 mg/kg D1 IV Q3W

  • IBI3014Drug

    20 mg/kg D1 IV Q3W

  • IBI3014Drug

    18 mg/kg D1 IV Q3W

Study groups in NCT06974812
Study groupRoleWhat they receive
IBI3014ExperimentalIBI3014 will be dosed until disease progression, toxicity intolerance, starting of new systemic anti-cancer treatment, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaching the maximum of 24 months, whichever occurs first.
Receives: Drug: IBI3014

What is being measured

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

  1. The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization

    Number ofparticipants with adverse events (AEs)

    Measured: 2 years after LPI

  2. Dose limiting toxicity (DLT) of IBI3014 in Phase 1 dose escalation

    The occurance of Dose limiting toxicity (DLT) per protocol to establish MTD or RDEs

    Measured: 21 days after LPI

  3. ORR per RECIST v1.1 in Phase 1 dose expansion and Phase 2 dose optimization

    The investigator assessed ORR per RECIST v1.1

    Measured: 2 years after LPI

  4. The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization

    Number ofparticipants with abnormal laboratorytests results

    Measured: 2 years after LPI

  5. The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization

    Number ofparticipants with abnormal physical examination findings

    Measured: 2 years after LPI

  6. The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization

    Number ofparticipants with abnormal vital signs

    Measured: 2 years after LPI

Secondary outcomes (7)

  1. Efficacy of IBI3014

    DOR, DoR, TTR, PFS as evaluated by investigator per RECIST v1.1 criteria and OS

    Measured: 2 years after LPI

  2. PK profile of IBI3014

    area under the curve (AUC)

    Measured: 2 years after LPI

  3. Incidence and characterization of anti-IBI3014 antibodies

    Rate of ADA and Nab

    Measured: 2 years after LPI

  4. PK profile of IBI3014

    area under the Cmax

    Measured: 2 years after LPI

  5. PK profile of IBI3014

    area under the Tmax

    Measured: 2 years after LPI

  6. PK profile of IBI3014

    area under the Clearance

    Measured: 2 years after LPI

  7. PK profile of IBI3014

    area under the t1/2 and others

    Measured: 2 years after LPI

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 2025
  2. Study start18 Apr 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06974812
Sponsor's protocol ID
CIBI3014A101
Status last verified
Jan 2026
First submitted
23 Apr 2025
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IBI3014 in people with Unresectable Locally Advanced or Metastatic Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 3 sites 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 20 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 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 Wei Zhang (15005136320, wei.zhang02@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Safety profile of patients in Phase 1 dose escalation part、Phase 1 dose expansion and Phase 2 dose optimization (time frame: 2 years after LPI). The study lists 6 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 NCT06974812.

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 29 Jan 2026.

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