Clinical trial · Interventional
A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies
A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast or Gynecologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with pegylated liposomal doxorubicin (PLD) with or without IPI-549 in participants with advanced metastatic triple-negative breast cancer (TNBC) or ovarian cancer, and etrumadenant in combination with nanoparticle albumin-bound-paclitaxel (NP) in participants with advanced metastatic TNBC.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| TNBC - Triple-Negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etrumadenant | Drug | — | UNRESOLVED |
| IPI-549 | Drug | — | UNRESOLVED |
| nanoparticle albumin-bound paclitaxel (NP) | Drug | Nab-paclitaxel | ALIAS |
| Pegylated liposomal doxorubicin (PLD) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Dose Escalation-Arm A
- description
- Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.
- interventionNames
- Drug: Etrumadenant
- Drug: Pegylated liposomal doxorubicin (PLD)
- type
- EXPERIMENTAL
- label
- Dose Escalation-Arm B
- description
- Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.
- interventionNames
- Drug: Etrumadenant
- Drug: nanoparticle albumin-bound paclitaxel (NP)
- type
- EXPERIMENTAL
- label
- Dose Escalation-Arm C
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Female participants, 18 years or older
* Measurable disease per radiographic evaluation
* Performance status 0 or 1
* Available archival tissue sample (within 2 years) or a fresh tumor biopsy may be required
* Adequate organ, cardiac, and bone marrow function
* Dose escalation
* Participants with breast cancer:
* Locally advanced or metastatic triple negative breast cancer (ER-negative, PgR-negative, and HER2-negative according to ASCO/CAP guidelines) with disease progression
* No available alternative or curative therapy
* Participants may have received any number of prior therapies for advanced/recurrent and progressive disease
* Participants with ovarian cancer:
* Locally advanced or metastatic ovarian cancer with disease progression
* No available alternative or curative therapy
* Participants may have received any number of prior therapies for advanced/recurrent and progressive disease
* Dose expansion
* Participants with breast cancer:
* Locally advanced or metastatic triple negative breast cancer (ER-negative, PgR-negative, and HER2-negative according to ASCO/CAP guidelines)
* Disease progression after no more than 3 prior lines of therapy
* Participants with ovarian cancer:
* Locally advanced or metastatic ovarian cancer that is platinum-resistant
* Disease progression after no more than 3 prior lines of therapy
Exclusion Criteria:
* Received a live, attenuated vaccine within 4 weeks prior to first study treatment
* Prior anticancer treatment including approved agents, systemic radiotherapy, or investigational therapy within 4 weeks prior first study treatment
* Cancer other than the disease under study within 2 years prior to study entry, except for some cancers with a low risk of spreading like non-melanoma skin cancers
* Inability to swallow oral medications
* Participant is breastfeeding, pregnant, or expects to become pregnant during the study
* Active autoimmune disease or documented history of autoimmune disease within 2 years prior to first study treatment
* History of peptic ulcer or stomach bleeding within 6 months prior to first study treatment
* Use of drugs contraindicated by the protocol within 4 weeks prior to and during study treatment
* Prior treatment with drugs that suppress the immune system within 2 weeks prior to first study treatment
* Presence of metastases in the brain or cancer spreading into the cerebrospinal fluid - CSF (leptomeningeal disease)
* HIV, Hepatitis B, and C test results negative prior to first study treatment
* Major surgery within 4 weeks prior to first study treatment
* Participants who have previously received maximum cumulative lifetime anthracycline dosage or baseline ejection fraction \<50% (on heart echography)References
Publications (0)
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