Informations générales (source: ClinicalTrials.gov)
A Phase 1a/1b, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75098 Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors
Interventional
Phase 1
BeOne Medicines (Voir sur ClinicalTrials)
décembre 2025
novembre 2028
17 octobre 2026
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK),
pharmacodynamics, and preliminary antitumor activity of BG-75098 alone and in combination
with BGB-43395 and fulvestrant in participants with advanced solid tumors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Karim AMRANE | 02/11/2026 15:30:04 | Contacter | ||
Critères
Tous
- Participants must have measurable disease as assessed by RECIST v1.1.
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG)
Performance Status of 0 or 1.
- Participants must have adequate organ function.
- Dose Escalation Part A: Participants with histologically or cytologically confirmed
advanced, metastatic, or unresectable solid tumors potentially associated with
cyclin-dependent kinase 2 (CDK2) dependency. Participants should have received prior
treatment with available standard-of-care (SOC) systemic therapies for
advanced/metastatic disease, or for whom standard therapy is not available or not
tolerated.
- Dose Escalation Part B: Patients with histologically or cytologically confirmed
advanced, metastatic, or unresectable solid tumors who have received ≥ 1 prior line
of systemic therapy in the metastatic setting.
- Dose Expansion Cohort 1: Participants with histologically or cytologically confirmed
advanced, metastatic, or unresectable CDK4/6 inhibitor-progressed solid tumors.
- Dose Expansion Cohort 2: Participants with advanced solid tumors. Participants with
primary platinum refractory disease are not eligible. Participants should have
received ≥ 1 line of platinum-containing chemotherapy and ≤ 4 prior therapeutic
regimens in the advanced/metastatic setting.
Exclusion Criteria:
- For all cohorts: Prior therapy selectively targeting CDK2 inhibition or degradation.
- For combination cohorts: Prior therapy selectively targeting CDK4. Prior CDK4/6
inhibitor standard of care therapy is permitted and required in local regions where
it is approved and available.
- Participants with active leptomeningeal disease or uncontrolled, untreated brain
metastasis.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.