New drug combo takes on Hard-to-Treat cancers in first human trial
NCT ID NCT06108050
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing an investigational drug called JZP898, both by itself and together with the immunotherapy pembrolizumab, in adults with advanced or metastatic solid tumors that have not responded to standard treatments. The main goals are to check safety, find the right dose, and see if the combination can shrink tumors. About 177 participants will take part across multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JZP898 (an investigational drug) and pembrolizumab (an immunotherapy)
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to other therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 177 participants, so the drug may not prove safe or effective. Side effects are unknown, and the combination with pembrolizumab could increase risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 177 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Adult ≥ 18 years of age * Histological or cytological diagnosis of advanced or metastatic solid tumor. 1. Previously treated participants with solid tumors that are amenable to CPI therapy (eg. NSCLC, melanoma, HNSCC, RCC, HCC, gastroesophageal carcinomas, UC, or CRC \[MSI-H\]) for whom, in the opinion of the investigator, there is no SoC available to convey clinical benefit. 2. Parts A2 and B: previously-treated (≥ 1 line of prior anticancer therapy) participants with select tumor types (NSCLC, HNSCC, melanomas, RCC, and UC) who have progressed on/after prior CPI therapy based on investigator assessment per RECIST version 1.1. * Participants in select tumor types: 1. NSCLC: eligible for platinum-based therapy and received platinum-based therapy prior to inclusion in the study. 2. HNSCC: eligible for platinum therapy and received platinum-based therapy prior to inclusion in this study. 3. Melanoma with known BRAFv600 mutation: received BRAF/MEKi therapy before this study. * ECOG score of 0 to 1. * Measurable disease per RECIST version 1.1 criteria. * Parts A1 and A2 only: willing to consent to mandatory tumor biopsies (both pretreatment and post-treatment with JZP898) unless medically infeasible * Adequate organ and bone marrow function as indicated by the following laboratory values (within 4 weeks prior to starting the study interventions) * Men and women of reproductive potential to observe highly effective birth control for the duration of treatment and for 4 months following the last dose of study drug; * Additional criteria may apply Exclusion Criteria * Unresolved toxicities from previous therapy that is \> Grade 1. * Hypersensitivity to mAb, IFNα, or study intervention components. * Primary CNS tumor or symptomatic CNS metastases. * Have a second primary malignancy treated within the previous 2 years (exceptions: non-metastatic, non-melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ). * Active autoimmune disease (in the last 2 years) requiring systemic steroids or immunosuppressive agents. * Active or history of pneumonitis (noninfectious) or interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Any history of suicidal behavior or any suicidal ideation * Clinically significant ischemic/hemorrhagic cerebrovascular accident/stroke and/or clinically significant active cardiovascular disease * Received any anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug * Received prior radiotherapy within 2 weeks of the first dose of study drug or have had a history of radiation pneumonitis * Major surgery within 2 weeks prior to the first dose of study intervention. * Participant is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study * Had a stem cell/solid organ transplant. * Receipt of prior IFNα therapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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California Cancer Associates for Research and Excellence
RECRUITINGEncinitas, California, 92024, United States
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California Cancer Associates for Research and Excellence
RECRUITINGFresno, California, 93270, United States
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Duke University Medical Center - Duke Cancer Institute
RECRUITINGDurham, North Carolina, 27710, United States
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Florida Cancer Specialists
RECRUITINGOrlando, Florida, 32827, United States
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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Sarah Cannon Research Institute at HealthONE
RECRUITINGDenver, Colorado, 80218, United States
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Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Texas Oncology - Baylor Charles A Sammons Cancer Center
RECRUITINGDallas, Texas, 75246, United States
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The University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Virginia Cancer Specialists
RECRUITINGFairfax, Virginia, 22031, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors