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NCT03893955

NCT03893955
Active, Not Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • Your liver, kidneys, and blood counts must be at healthy enough levels, as shown by recent lab tests.
  • You must be generally well enough to carry out light activity and care for yourself (a doctor will assess this using a standard scale called ECOG, scoring 0 or 1).
  • (Dose-Escalation – Arm A): You have an advanced solid tumour that has continued to grow or spread after trying standard treatments, or you were unable to tolerate or chose not to have those treatments.
  • (Dose-Escalation – Arm B): You have been diagnosed with non-small-cell lung cancer (NSCLC), confirmed by a tissue or cell sample, and your cancer got worse during or after treatment with a specific type of immunotherapy (anti-PD-1 or PD-L1 therapy) and a platinum-based chemotherapy.
  • (Dose-Expansion – Arms 1, 2 & 3): You have been diagnosed with a specific type of breast cancer called triple-negative breast cancer (TNBC), confirmed by a tissue or cell sample, your cancer has progressed after at least one treatment including a taxane chemotherapy drug in the advanced or recurrent setting, and you have never received immunotherapy.
  • (Dose-Expansion – Arm 4): You have confirmed TNBC, have not yet received any anti-cancer treatment for TNBC, and a lab test on your tumour tissue shows a protein called PD-L1 is not present.
  • (Dose-Expansion – Arm 5): You have confirmed NSCLC and your cancer got worse during or after immunotherapy (anti-PD-1 or PD-L1 therapy) and platinum-based chemotherapy.

Who may not be able to join:

  • You have a history of inflammatory bowel disease or inflammation of the lungs (pneumonitis).
  • You have cancer that has spread to the brain or spinal cord and is not currently under control.
  • You have a second, separate cancer that is serious, requires treatment, or is not currently stable.
  • You have had a major operation within the last 28 days before starting the trial, or your surgical wound has not fully healed.
  • You previously received an immunotherapy drug targeting PD-1 or PD-L1 and experienced any of the following: a severe immune-related side effect (Grade 3 or worse); needed steroid tablets or injections to treat a side effect; had an allergic reaction to the immunotherapy drug; or had to stop taking the immunotherapy drug because of side effects.

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
AbbVie
Registry
clinicaltrials_gov
Start date
21 May 2019
Est. completion
1 March 2026

Where this trial is recruiting

🇦🇺 Australia 🇫🇷 France 🇮🇱 Israel 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

Dose Expansion: Objective Response Rate (ORR); Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368; Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181

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