Clinical trial · Interventional
A Study of BGC515 Capsules in Subjects With Advanced Solid Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BGC515 Capsules in Patients With Advanced Solid Tumors
NCT06452160CI-TRIAL-00079667recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this open-label, dose escalation and dose expansion Phase I clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGC515 administered once daily in 3 weeks cycles in solid tumor patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelioid Hemangioendothelioma(EHE) | Epithelioid Hemangioendothelioma | ONTOLOGY_EXACT | 0.85 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BGC515 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- BGC515 Capsules will be administered orally in 21 day cycles, once daily (QD). Patients will be enrolled into escalating dose levels during the Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) and the Recommended Dose(s) for Expansion (RDE).
- interventionNames
- Drug: BGC515
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- BGC515 Capsules will be administered orally in 21 day cycles at MTD/RDE defined dose,once daily (QD), in patients with malignant mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors.
- interventionNames
- Drug: BGC515
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Having signed the written Informed Consent Form * Male or female aged ≥18 years * Life expectancy ≥12 weeks * Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1 * Dose escalation phase: Histologically or cytologically confirmed locally advanced or metastatic mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors who have experienced progressive disease or treatment intolerability after receiving the standard-of-care, or refuse to receive or have no access to the standard-of-care * Dose expansion phase: Histologically or cytologically confirmed locally advanced or metastatic MM, EHE, etc. regardless of Hippo signaling pathway abnormalities, or other advanced solid tumors with Hippo signaling pathway abnormalities, who have experienced progressive disease or treatment intolerability after receiving the standard-of-care, or refuse to receive or have no access to the standard-of-care * At least one measurable lesion Exclusion Criteria: * Previous or current use of transcriptional enhanced associate domain (TEAD) inhibitors * Inadequate wash-out of prior therapies described per protocol * Patients with severe or unstable systemic disease, unstable or symptomatic Central Nervous System (CNS) metastasis * Clinically significant cardiovascular disease as defined in the protocol * Women who are pregnant or breastfeeding * Hypersensitivity to the active pharmaceutical ingredient or any excipient of BGC515 * Study staff member or relative of a study staff member directly related to this clinical trial, or a subordinate of the Investigator in this trial or an employee of the Sponsor, though not directly related to this trial * Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.