A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2025-05-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Cancers Solid Tumor Cancer Solid Tumor Malignancy Urothelial Cancer (Urinary Bladder, Ureters, or Renal Pelvis Cancer) Metastatic Solid Tumor Locally Advanced Solid Tumor Urothelial Cancer of Renal Pelvis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

This study is divided into three stages:

The first stage is the dose escalation stage that evaluates how much of XL495 alone patients can safely tolerate.

The second is the dose finding stage that evaluates how much of XL495 to give patients in combination with other anti-cancer medications.

The third stage is the expansion stage that evaluates how XL495 performs in patients in combination with other anti-cancer medications.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation XL495

Group(s) of participants with advanced metastatic tumors who will receive increasing doses of XL495.

Group Type EXPERIMENTAL

XL495

Intervention Type DRUG

oral doses of XL495

Dose Finding XL495 + ADC cytotoxic agents

Group(s) of participants with advanced metastatic tumors who will receive XL495 and Antibody drug conjugate (ADC) cytotoxic agents together at increasing doses.

Group Type EXPERIMENTAL

XL495

Intervention Type DRUG

oral doses of XL495

ADC cytotoxic agents

Intervention Type DRUG

intravenous infusion of anti-cancer combination agent

Expansion XL495 + ADC cytotoxic agents

Group(s) of participants with urothelial cancer who will receive XL495 and ADC cytotoxic agents at the recommended dosage(s) of expansion (RDE \[s\]) determined during the dose-escalation and dose-finding stages.

Group Type EXPERIMENTAL

XL495

Intervention Type DRUG

oral doses of XL495

ADC cytotoxic agents

Intervention Type DRUG

intravenous infusion of anti-cancer combination agent

Interventions

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XL495

oral doses of XL495

Intervention Type DRUG

ADC cytotoxic agents

intravenous infusion of anti-cancer combination agent

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No