Phase 1 Stomach Cancer Trial, Recruiting NCT05005403 Sponsor: AbbVie Condition: Stomach Cancer
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Phase 1 Stomach Cancer Trial, Recruiting

NCT05005403
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • A recent tissue sample (biopsy) from the cancer must be available — either taken within the last 6 months before joining, or from stored tissue — with no cancer treatment given in between.
  • People whose general health and ability to carry out daily activities is rated as fully active or restricted only in strenuous activity (confirmed using a standard medical scale), and who are expected to live at least 3 months.
  • People whose cancer can be measured on scans using a standard set of medical measurement rules.
  • People whose blood test results meet specific levels outlined in the trial's requirements (confirm with trial site).
  • People with advanced or metastatic non-small cell lung cancer (NSCLC) that has continued to grow after standard treatments, including chemotherapy and an immune checkpoint therapy (anti-PD-(L)1). People with specific gene changes in their tumour are also eligible if targeted treatments for those genes have already been tried.
  • People with advanced or metastatic head and neck squamous cell cancer (HNSCC) that has continued to grow after platinum-based chemotherapy and an immune checkpoint therapy.
  • People with a type of bowel cancer called microsatellite stable colorectal cancer (MSS-CRC) that has continued to grow after a specific list of standard treatments, and whose cancer does not have a feature called MSI-high or mismatch repair deficiency.
  • People with advanced or metastatic stomach or gastroesophageal junction cancer (GEA) that has continued to grow after at least one round of chemotherapy, and where relevant, after immune checkpoint therapy and/or HER2-targeted treatment.
  • People with a specific type of advanced ovarian, fallopian tube, or peritoneal cancer (HGSOC) that has continued to grow after standard treatment and is not suitable for surgery. Those with platinum-resistant disease must not have received more than 5 prior lines of treatment.
  • People with advanced or metastatic pancreatic adenocarcinoma (including adenosquamous carcinoma, or cases following Whipple surgery) that has continued to grow after standard treatment.
  • People with triple negative breast cancer (TNBC) that has continued to grow after one or two prior systemic treatments — at least one of which must have included a taxane — and who have not previously received immunotherapy targeting T-cell co-stimulation.

Who may not be able to join:

  • People with pancreatic neuroendocrine or acinar cell carcinoma (rather than adenocarcinoma), or people with blood clotting disorders or a history of, or elevated risk of, blood clots in the veins or lungs.
  • People who have had major surgery within 28 days before the first dose of the trial treatment.
  • People with an active autoimmune disease or immune deficiency condition, with some limited exceptions (confirm with trial site).
  • People receiving combination treatment in the trial who previously experienced a severe (grade 3 or higher) immune-related side effect, inflammation of the lungs, or a serious allergic reaction from an anti-PD-1/PD-L1 immune therapy. Certain heart-related conditions or events may also affect eligibility for the combination treatment arm (confirm with trial site).
  • People who are pregnant.
  • People who have received anti-cancer treatment within a recent window before joining (based on the specific drug's timeframe), or who have received certain other medications including agents targeting a protein called CCR8, live vaccines, or immune-suppressing medications, with some limited exceptions (confirm with trial site).

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
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.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: ABBVIE INC., AbbVie

Phone: 844-663-3742

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
1 November 2021
Est. completion
1 July 2027

Where this trial is recruiting

🇨🇦 Canada 🇮🇱 Israel 🇯🇵 Japan 🇰🇷 South Korea 🇹🇼 Taiwan 🇺🇸 United States

Primary endpoints

Number of Participants with Adverse Events (AE); Maximum Observed Serum Concentration (Cmax) of Azirkitug; Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug; Terminal Elimination Half-Life (t1/2) of Azirkitug; Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug; Azirkitug Antidrug Antibody (ADA); Azirkitug Neutralizing Antidrug Antibody (nADA); Cmax of Budigalimab; Tmax of Budigalimab; t1/2 of Budigalimab; AUC of Budigalimab; Budigalimab ADA; Budigalimab nADA; Cmax of Telisotuzumab Adizutecan; Tmax of Telisotuzumab Adizutecan; t1/2 of Telisotuzumab Adizutecan...

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: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov