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Monoclonal Antibodies

XTX101 + Atezolizumab for Solid Cancers

Phase 1 & 2
Recruiting
Research Sponsored by Xilio Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with extensive stage small cell lung cancer (SCLC) after at least 1 line of prior therapy
Patients with histologically or cytologically confirmed solid tumor malignancy for which anti-PD-1 or anti-PD-L1 treatment is approved and has progressed on or after prior anti-PD-1 or anti-PD-L1 therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is designed to study the safety and tolerability of a new drug, XTX101, either on its own or in combination with another drug, pembrolizumab, in patients with advanced solid tumors.

Who is the study for?
This trial is for adults with advanced solid tumors that have failed standard therapy or where no curative treatment exists. It's also open to those with metastatic melanoma who haven't had anti-PD-1/L-1 therapy, and people whose cancer progressed after such treatments. Participants must be in good physical condition (ECOG 0 or 1) and have proper organ function.Check my eligibility
What is being tested?
The study is testing XTX101 alone and combined with Atezolizumab in patients with various advanced solid tumors. It's a first-in-human study, meaning it's the first time these drugs are being tested in people, to see how safe they are and how well they're tolerated when given together or separately.See study design
What are the potential side effects?
While specific side effects of XTX101 aren't detailed here, similar cancer therapies often cause fatigue, nausea, skin reactions, immune-related conditions like inflammation of organs (colitis), potential infusion reactions from the drug entering the body, as well as increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced small cell lung cancer and have undergone at least one treatment.
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My cancer has worsened despite prior anti-PD-1 or anti-PD-L1 therapy.
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I am fully active or can carry out light work.
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My prostate cancer has spread and not responded to at least 2 treatments.
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My colorectal cancer is stable and I've had at least 2 prior treatments.
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My cancer is advanced or has spread, and standard treatments haven't worked or aren't suitable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Dose Limiting Toxicities (DLTs) in Part 1A
Incidence of Dose Limiting Toxicities (DLTs) in Part 1C
Incidence of changes in clinical laboratory abnormalities
+1 more
Secondary outcome measures
Antidrug antibody (ADA) occurrence and titer in serum
Area under the curve (AUC)
Half-life (T1/2)
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 1C - XTX101 Dose Escalation in Combination with AtezolizumabExperimental Treatment2 Interventions
Part 1C will receive a labeled dose of atezolizumab in combination with XTX101.
Group II: Part 1B - Pharmacodynamic (PD) Dose ExpansionExperimental Treatment1 Intervention
Part 1B XTX101 at the RP2D will be administered to further examine XTX101 as monotherapy in patients with select advanced solid tumors.
Group III: Part 1A - XTX101 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Part 1A Dose Escalation of XTX101 administered in ascending doses to patients with advanced or metastatic solid tumors to find the recommended phase 2 dose (RP2D).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheIndustry Sponsor
2,431 Previous Clinical Trials
1,089,972 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,575 Total Patients Enrolled
Xilio Development, Inc.Lead Sponsor
2 Previous Clinical Trials
363 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04896697 — Phase 1 & 2
Solid Tumors Research Study Groups: Part 1A - XTX101 Monotherapy Dose Escalation, Part 1C - XTX101 Dose Escalation in Combination with Atezolizumab, Part 1B - Pharmacodynamic (PD) Dose Expansion
Solid Tumors Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04896697 — Phase 1 & 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04896697 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you enumerate where this clinical research is taking place in the city?

"Presently, this study is running at 10 distinct locations across the country. A few of them include Encinitas, Pittsburgh and Webster. To reduce travel costs if you choose to take part in the trial, it's important to pick a site closest to your residence."

Answered by AI

Are there any existing investigations into the properties of XTX101?

"XTX101 was initially trialled in 2010 by City of Hope. As it stands, there are 251 completed trials and 961 active studies being conducted at Encinitas, California."

Answered by AI

What medical ailments can be alleviated with XTX101?

"XTX101 is the drug of choice for treating malignant neoplasms, but can also help manage other ailments like microsatellite instability high and unresectable melanoma, as well as provide relief from chemotherapy-induced progression."

Answered by AI

What is the size of the cohort under evaluation in this trial?

"In order to execute the trial, Merck Sharp & Dohme LLC are recruiting a total of 144 individuals who satisfy all enrollment criteria. The research will be conducted in various locations such as California Cancer Associates for Research and Excellence (cCARE) in Encinitas, CA and University of Pittsburgh Medical Center- Hillman Cancer Center located in Pittsburgh, PA."

Answered by AI

Is this clinical study currently accepting new participants?

"Affirmative. Per the information accessible on clinicaltrials.gov, this clinical experiment that was initially made available on September 13th 2021 is actively seeking participants. A total of 144 patients are being sought from 10 different medical sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
XTX101 Monotherapy and XTX101 and Atezolizumab Combination Therapy in Patients With Advanced Solid Tumors
2021. "XTX101 Monotherapy and XTX101 and Atezolizumab Combination Therapy in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04896697.
~41 spots leftby Mar 2026
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