Phase 1 Kidney Cancer Trial, Recruiting NCT04777994 Sponsor: Calico Life Sciences LLC Condition: Kidney Cancer
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Phase 1 Kidney Cancer Trial, Recruiting

NCT04777994
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You weigh at least 35 kilograms (about 77 pounds).
  • You are able to carry out basic daily activities and care for yourself, with limited or no restriction due to your illness (confirm with trial site for exact activity level required).
  • Doctors expect you to live for at least 12 weeks or more.
  • Your recent blood and lab test results meet the specific levels required by the trial (confirm with trial site for exact values).
  • A recent heart tracing (ECG) shows your heart rhythm is within a specific normal range and has no significant abnormalities.
  • Your cancer can be measured on scans using standard medical criteria.
  • (For the general dose-finding parts of the trial): You have a confirmed advanced or spreading cancer for which standard treatments have not worked or do not exist, and you have had at least one prior cancer treatment.
  • (For the monotherapy expansion part): You have head and neck cancer, non-small cell lung cancer, or a specific type of kidney cancer that has come back or is not responding to treatment, you have had at least one prior treatment including a specific type of immunotherapy, and that immunotherapy either worked for a period of time or kept your cancer stable for more than 6 months.
  • (For the immunotherapy combination expansion part): Depending on your cancer type, you either previously responded to a specific type of immunotherapy, or your cancer progressed while on that immunotherapy — and your cancer is one of the types specified in the trial (confirm with trial site which applies to you).
  • (For the targeted therapy combination expansion part): You have a specific type of kidney cancer that has come back and you have had no more than one prior treatment with a specific type of targeted therapy drug.

Who may not be able to join:

  • You have brain or spinal fluid metastases that have not been treated, or treated ones that still require steroid medication or have not been stable for at least 28 days.
  • You still have significant side effects (grade 2 or higher) from a previous cancer treatment, apart from hair loss.
  • You have significant ongoing nerve damage in your hands or feet (grade 2 or higher) from previous treatment.
  • You have a history of hepatitis B, hepatitis C, or HIV infection.
  • You have had a serious heart problem in the past 6 months, such as heart failure, a heart attack, inflammation around the heart, or a significant irregular heartbeat.
  • You have had significant liver disease in the past 6 months.
  • You have a serious medical or mental health condition that the trial doctor believes would make it unsafe or unsuitable for you to participate.
  • You have an uncontrolled hormonal gland disorder (confirm with trial site).
  • You have a digestive condition that makes it difficult to absorb tablets or capsules taken by mouth, or you are unable to swallow capsules.
  • If you previously received immunotherapy, you may not be eligible if you experienced serious lung inflammation, a severe immune-related side effect (grade 3 or higher), an allergic reaction to the drug, or had to stop taking it due to side effects.
  • You have an active autoimmune disease (where your immune system attacks your own body) that has required treatment in the past 2 years — though some conditions like thyroid disorders, vitiligo, or certain skin conditions may be exceptions.
  • You have previously received an organ transplant or a bone marrow/stem cell transplant from a donor.
  • You have a history of another cancer, unless it has been gone for 3 or more years and is considered low risk, or it was a successfully treated skin cancer or early-stage cancer with no sign of return.
  • You have a history of scarring or inflammation of the lungs (interstitial lung disease or pneumonitis).
  • You had major surgery within 28 days before starting the trial.
  • You currently have an active COVID-19 infection.
  • (For the targeted therapy combination part only): You have had a recent significant bleeding episode, including coughing up blood, vomiting blood, or bloody stools, or your blood pressure is poorly controlled.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Calico Life Sciences LLC, Calico

Phone: 650-754-6200

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Calico Life Sciences LLC
Registry
ClinicalTrials.gov
Start date
9 March 2021
Est. completion
1 October 2026

Where this trial is recruiting

🇫🇷 France 🇮🇱 Israel 🇯🇵 Japan 🇰🇷 South Korea 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-484 (Monotherapy); Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of Programmed Cell Death-1 (PD-1) Inhibitor (Combination therapy); Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of VEGFRTKI (Combination therapy) Maximum plasma/serum concentration of PD-1 inhibitor; Dose Escalation: Time To Cmax (Tmax) Of ABBV-CLS-484 (Monotherapy); Dose Escalation: Time To Cmax (Tmax) Of PD-1 Inhibitor (Combination therapy); Dose Escalation Time to Cmax (Tmax) of VEGFR TKI (Combination th...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov