Clinical trial · Interventional
A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid Tumors
A Dose-escalation, Dose-finding, and Expansion Study of XL495 as a Single Agent and in Combination Therapy in Participants With Locally Advanced or Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company Decision
Summary
Brief summary (as posted)
The goal of this study is to obtain safety, tolerability, PK, and preliminary clinical antitumor activity for XL495 as a single agent and in combination with select cytotoxic agents in participants with locally advanced or metastatic tumors for whom life-prolonging therapies do not exist or available therapies are intolerable/no longer effective.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Solid Cancers | Malignant Solid Neoplasm | ALIAS | 0.90 |
| Solid Tumor Cancer | — | UNRESOLVED | — |
| Solid Tumor Malignancy | — | UNRESOLVED | — |
| Urothelial Cancer of Renal Pelvis | — | UNRESOLVED | — |
| Urothelial Cancer (Urinary Bladder, Ureters, or Renal Pelvis Cancer) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADC cytotoxic agents | Drug | — | UNRESOLVED |
| XL495 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Escalation XL495
- description
- Group(s) of participants with advanced metastatic tumors who will receive increasing doses of XL495.
- interventionNames
- Drug: XL495
- type
- EXPERIMENTAL
- label
- Dose Finding XL495 + ADC cytotoxic agents
- description
- Group(s) of participants with advanced metastatic tumors who will receive XL495 and Antibody drug conjugate (ADC) cytotoxic agents together at increasing doses.
- interventionNames
- Drug: XL495
- Drug: ADC cytotoxic agents
- type
- EXPERIMENTAL
- label
- Expansion XL495 + ADC cytotoxic agents
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * For All Participants * Have received at least one standard therapy unless it does not exist, or available therapies are intolerable or no longer effective. * For participants, who qualify for approved molecularly selected therapies such as RAS inhibitors, they must have progressed on, relapsed from, been intolerant to, ineligible, or refused those therapies. * Expansion Stage * Diagnosis of metastatic advanced UC (primary tumor: renal pelvis, ureter, urinary bladder, or urethra). * At least one measurable lesion as defined by RECIST, version 1.1. * Participants must be eligible for sacituzumab govitecan treatment as their next line of therapy. * At least one but no more than 3 prior lines of therapy. * Eastern Cooperative Oncology Group (ECOG) Performance Status (0-2 for monotherapy; 0-1 for combo) Exclusion Criteria * Prior anticancer treatment, including: * Radiation therapy within 2 weeks before first dose of study treatment. * Known brain metastases or cranial epidural disease * Current or recent severe illness * Known history or positive test for human immunodeficiency virus (HIV) unless meets specific criteria. * Active infection with hepatitis B virus or hepatitis C virus. * Malabsorption syndrome. * History of solid organ, autologous or allogenic stem cell transplant. * Diagnosis of another cancer within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with standard therapy. * Active autoimmune disease with skin involvement.
References
Publications (0)
Data not yet available