No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
362 (estimated)
Sponsor
Arcus Biosciences, Inc. · Industry
Who this trial is looking for
This trial is looking for people with advanced kidney cancer or other solid tumors. Participants will take a drug called casdatifan alone or with other treatments to see how safe it is.
Are You a Good Fit for This Trial?
You may be able to join if
I have at least one measurable tumor
My cancer has no other treatment options available
I have clear cell renal cell carcinoma
I have a performance status score of 1 or less
My kidney function is good with a creatinine clearance of 40 mL/min or more
You may not be able to join if
I have used any live vaccines in the last 4 weeks
I have any serious heart, lung, or other health issues
I had major surgery or trauma in the last 28 days
I have received certain prior cancer treatments
I have known psychiatric or substance abuse problems
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to evaluate the safety and tolerability of:
* casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and
* casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose …
The purpose of this study is to evaluate the safety and tolerability of:
* casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and
* casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.
Trial Locations
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City
State
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Status
Eligibility Criteria
Key Inclusion Criteria:
* Must have at least one measurable lesion per RECIST guidance
* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
* Disease-specific criteria for dose escalation:
* Participants may have any pathologically confirmed solid tumor type where no other…
Key Inclusion Criteria:
* Must have at least one measurable lesion per RECIST guidance
* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
* Disease-specific criteria for dose escalation:
* Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
* Creatinine clearance ≥ 40 mL/min
Disease-specific criteria for dose-expansion:
* Histologically confirmed ccRCC
* Creatinine clearance ≥ 40 mL/min
Key Exclusion Criteria:
* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
* Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous
* History of trauma or major surgery within 28 days prior to the first dose of investigational product
* For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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