Not Yet RecruitingPhase 1/2

Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

China282 participantsStarted 2026-06-01

Plain-language summary

To evaluate the safety and tolerability of IBI3005 combination therapy in participants with advanced solid tumors; to evaluate the antitumor activity of IBI3005 combination therapy in participants with advanced solid tumors.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Has signed a written informed consent form (ICF) and is able to comply with the scheduled study visits and related procedures.
. Age ≥ 18 years, irrespective of gender.
. Confirmed diagnosis of locally advanced unresectable or metastatic solid tumor.
. Expected survival ≥ 12 weeks.
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
. Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to the first study drug administration.
. Adequate bone marrow and organ function.
. Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.

Exclusion criteria

. Participation in any other interventional clinical study, except for observational (non-interventional) studies or the follow-up period after the end of study treatment in an interventional study.
. Prior treatment with antibody-drug conjugate (ADC) drugs bearing a camptothecin or its derivative (topoisomerase I inhibitor) small-molecule payload.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of subjects with adverse events

Timeframe: Up to 3 years

Number of subjects with treatment emergent adverse events

Timeframe: Up to 3 weeks

Number of subjects with adverse events of special interest

Timeframe: Up to 3 years

Number of subjects with serious adverse events

Timeframe: Up to 3 years

Dose limiting toxicities (DLTs)

Timeframe: Up to 3 weeks

Number of subjects with clinically significant changes in laboratory tests results

Timeframe: Up to 3 years

Number of subjects with clinically significant changes in physical examination results

Timeframe: Up to 3 years

Trial details

NCT IDNCT07612137

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Yang Luo

+86 21 3183 7200 yang.luo@innoventbio.com

View on ClinicalTrials.gov More Solid Tumor trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Has signed a written informed consent form (ICF) and is able to comply with the scheduled study visits and related procedures.
. Age ≥ 18 years, irrespective of gender.
. Confirmed diagnosis of locally advanced unresectable or metastatic solid tumor.
. Expected survival ≥ 12 weeks.
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
. Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to the first study drug administration.
. Adequate bone marrow and organ function.
. Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC.

Exclusion criteria

. Participation in any other interventional clinical study, except for observational (non-interventional) studies or the follow-up period after the end of study treatment in an interventional study.
. Prior treatment with antibody-drug conjugate (ADC) drugs bearing a camptothecin or its derivative (topoisomerase I inhibitor) small-molecule payload.

What they're measuring

Number of subjects with adverse events

Timeframe: Up to 3 years

Number of subjects with treatment emergent adverse events

Timeframe: Up to 3 weeks

Number of subjects with adverse events of special interest

Timeframe: Up to 3 years

Number of subjects with serious adverse events

Timeframe: Up to 3 years

Dose limiting toxicities (DLTs)

Timeframe: Up to 3 weeks

Number of subjects with clinically significant changes in laboratory tests results

Timeframe: Up to 3 years

Number of subjects with clinically significant changes in physical examination results

Timeframe: Up to 3 years