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RecruitingPhase 2

A Study of IBI363 in Subjects with Advanced Solid Malignancies

A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Phase 2 study tests IBI363 in adults with advanced solid cancers that have not responded to treatment. It looks at how well the drug works, how safe it is, and how well people can handle its side effects.

This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can understand the study and give written consent to take part in all required tests and procedures.
  • Are age 18 or older.
  • Are fully active or can do light work, even if hard physical activity is limited.
  • Are expected to live at least 3 months.

Who can't join

  • Have bone marrow or organs that do not work well enough. Bone marrow makes blood cells.
  • Had chemotherapy or a targeted small-molecule cancer drug within 2 weeks or 5 drug half-lives before the first study dose. A half-life is the time it takes the body to clear half of a drug.
  • Received nitrosoureas or mitomycin C, types of cancer drugs, within 6 weeks before the first study dose or during the study.
  • Received an antibody-based cancer drug within 4 weeks before the first study dose.
  • Received a live vaccine within 28 days before the first study dose, or plan to get one during the study.
  • Still have side effects from past cancer treatment that are more than mild and have not returned to their earlier level before the first study dose. Exceptions include hair loss, tiredness, skin color changes, and other effects the study doctor considers safe.
  • Had major surgery within 4 weeks before the first study dose, or expect to have it during the study. A needle biopsy, which takes a small tissue sample, does not count.
  • Have serious wounds, injuries, or open sores that have not healed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Subjects have 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 subjects ≥ 18 years old; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 4. Anticipated life expectancy of ≥ 3 months; Exclusion Criteria: 1. Inadequate bone marrow and organ function; 2. Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose 3. Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study; 4. Has adverse reactions resulting from previous antitumor 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 investigator' discretion) or baseline prior to the first dose of the study drug; 5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.

Study sites (9)

CA

FL

KS

MI

TX

WA