Back to Ovarian Cancer

NCT05277051

NCT05277051
Active, Not Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • Women who are not pregnant or breastfeeding, and who are either unable to become pregnant or are using a highly effective form of birth control (with a failure rate of less than 1% per year) during the study and for a set period after treatment ends
  • Women of childbearing age must have a negative pregnancy test taken 24–48 hours before starting the study treatment
  • Male participants in one specific part of the trial (Arm I) must agree to use contraception themselves, and their female partner must also use contraception if applicable
  • You have a confirmed diagnosis (through a tissue or cell sample) of one of these cancers that has come back locally, spread to other parts of the body, or cannot be cured with current treatments: head and neck cancer, non-small cell lung cancer, breast cancer, kidney cancer (clear cell type), stomach cancer, colorectal cancer, endometrial cancer, or ovarian/fallopian tube/peritoneal cancer
  • Your cancer has gotten worse after standard treatments, or standard treatments did not work, were too difficult to tolerate, were not appropriate for you, or no further standard treatment options exist
  • Your cancer can be measured on scans according to standard criteria (called RECIST 1.1)
  • You are generally able to carry out everyday activities with little or no limitation (a standard health score of 0 or 1)
  • You are expected to live for at least 12 weeks
  • Your heart, liver, kidneys, and other organs are functioning well enough, as defined by the trial's guidelines
  • If joining a specific sub-group of the trial, you agree to have a fresh tumor tissue sample taken during the screening period and again about 6 weeks after starting treatment

Who may not be able to join:

  • You have previously received treatment targeting a specific immune pathway called PVRIG (including a drug called COM701 or similar), or treatments targeting related immune checkpoints called TIGIT or CD96
  • For one specific part of the trial (Arm I only): you have previously received certain drugs called orlotamab, enoblituzumab, I-Dxd, or any other treatment targeting a protein called B7-H3
  • You have received other immunotherapy, chemotherapy, targeted therapy, biological therapy, or radiation therapy within certain time periods before starting the trial (confirm specific timeframes with trial site)
  • You have taken part in another clinical trial and received an experimental treatment within the past 4 weeks, or within 5 "half-lives" of that drug — whichever is shorter (confirm with trial site)
  • You have previously had a bone marrow transplant (from a donor or your own cells) or any other organ transplant
  • You had a serious immune-related side effect (Grade 3 or higher) from a previous immunotherapy treatment that caused you to stop that treatment
  • You had any level of heart inflammation (myocarditis) caused by a previous immunotherapy treatment
  • You still have side effects from a previous cancer treatment that have not mostly resolved (confirm acceptable levels with trial site)
  • You have been diagnosed with another cancer that has grown or needed active treatment within the last 2 years

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 1
Sponsor
GlaxoSmithKline
Registry
clinicaltrials_gov
Start date
22 March 2022
Est. completion
31 August 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇯🇵 Japan 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Arms A, B, C, I: Number of Participants with dose-limiting toxicities (DLTs); Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov