Metastatic CancerPhase 2STRIPeNCT07346209
Real-world Trial of Individualized Precision Oncology
A Phase 2 study testing Molecularly matched therapy in people with Metastatic Cancer and Unresectable Carcinoma, run by University of California, San Diego at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if drugs that are matched to tumor DNA mutations work to treat metastatic solid cancers in adults. The main questions it aims to answer are: Is tumor worsening delayed for a longer period of time if patients take drugs that match DNA mutations, compared to if they take… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Unresectable Carcinoma
- What is being tested?
- Molecularly matched therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Sep 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Aged at least 18 years.
- Metastatic or unresectable solid cancers (all) with a 2-year cancer-associated mortality of ≥ 50%, or immediate prior progression free survival < 4 months, or life expectancy between 6 and 16 months as determined at prescreening and/or enrollment due to cancer diagnosis.
- Previous treatment with up to 2 lines of cancer therapy before enrollment.
- Available results of tumor imaging performed within 4 weeks prior to randomization or eligible to obtain imaging as part of routine care. Note that patients are not eligible if their tumor imaging was performed more than 4 weeks before randomization, or if the imaging to be performed at screening is within 6 weeks of their previous imaging.
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- Measurable disease by RECIST v 1.1 based on computed tomography, magnetic resonance imaging or positron emission tomography/computed tomography scan performed within 4 weeks prior to randomization.
- Case discussed by Molecular Tumor Board with consensus treatment recommendation(s).
- Presence of at least 1 tumor-derived molecular alteration/biomarker with a molecularly matched therapy option per Molecular Tumor Board recommendation.
- Molecular profile needs to be performed in tumor tissue or circulating tumor DNA collected in the 6 months before enrollment and analyzed by next generation sequencing, immunohistochemistry, and/or alternative technology in a Clinical Laboratory Improvement Amendments-accredited and College of American Pathologists-certified clinical laboratory.
- All prior pathology and molecular studies may be reviewed and considered by the Molecular Tumor Board.
- Molecularly matched therapy options are restricted to Food and Drug Administration-approved drugs.
- Eligible for at least 1 additional unmatched standard of care therapy.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- At the time of the screening/baseline visit, patients must be off prior antibody therapy for at least 3 half-lives, and other anti-tumor agents for at least 5 half-lives, or total 3 weeks from the last day of treatment, whichever is shortest.
- Adequate hematologic, hepatic, and renal function, as specified below:
- Absolute Neutrophil Count ≥ 1.5 x 10^9/L
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 50 x 10^9/L
- Serum total bilirubin < 2.0 x upper limit of normal
- Aspartate aminotransferase and alanine aminotransferase ≤ 5 x upper limit of normal
- Serum creatinine ≤ 1.5 x upper limit of normal or calculated creatinine clearance ≥ 50ml/min based upon the Cockcroft-Gault Equation [CrCl = (140-age) * actual weight (in kg) * (0.85 if female) / (72 * Cr)].
- For participants able to become pregnant or cause a pregnancy: use of highly effective contraception during treatment with the study therapy and for 3 months afterwards.
Who cannot join
- Presence of very high tumor mutational burden as ≥ 20 mutations/megabase.
- Presence of a microsatellite instability-high as defined by the testing laboratory.
- Deficiency of mismatch repair genes: MLH1, MSH2, MSH6, or PMS2.
- Molecular Tumor Board treatment recommendation is a monotherapy with an immune checkpoint inhibitor.
- Molecular Tumor Board treatment recommendation is considered a standard of care regimen per NCCN guidelines (including treatments considered useful in certain circumstances).
- Example 1: Presence of BRAF V600E in lung cancer as the sole molecularly matched target is ineligible, given Food and Drug Administration approval of combination BRAFi/MEKi.
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- Example 2: Presence of BRAF V600E and CDKN2A mutation in lung cancer is eligible, if the Molecular Tumor Board recommendation is the non-standard of care combination of BRAFi/MEKi + CDK4/6i
- Example 3: Presence of KRAS G12C in breast cancer is eligible as the use of KRAS inhibitors for this specific tumor type is not standard of care.
- Example 4: Presence of KRAS G12A mutation in colon cancer is eligible if the Molecular Tumor Board recommendation is for non-standard of care MEKi.
- Newly diagnosed symptomatic brain metastases requiring immediate treatment. Note that patients with asymptomatic or treated stable brain metastases not requiring steroids can be enrolled.
- Increase of Eastern Cooperative Oncology Group performance status of ≥ 1 point in the 30 days prior to enrollment.
- Pregnancy or lactation.
- Known allergic reactions to components of the therapy.
- Other conditions that preclude study participation at the discretion of the treating physician (e.g., organ or bone marrow dysfunction).
- Patient is in hospice care.
- Two oncologists disagree on prognosis or cancer resectability.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: STudy of Real-world Individualized Precision-oncology
The goal of this clinical trial is to learn if drugs that are matched to tumor DNA mutations work to treat metastatic solid cancers in adults. The main questions it aims to answer are:
Is tumor worsening delayed for a longer period of time if patients take drugs that match DNA mutations, compared to if they take standard of care drugs?
Read more
Researchers will compare drugs matched to tumor DNA mutations to standard of care drugs to see if the matched drugs work better, and to see if tumor worsening can be delayed for longer the more DNA mutations the drugs target.
Participants will:
Take drugs matched to tumor DNA mutations or standard of care drugs based on the regular dosing schedule of the drugs.
Visit the clinic every approximately 2 months for checkups and tumor imaging.
Read the detailed description
Next generation sequencing and multi-omic technologies have revealed that advanced or metastatic solid cancers often have complex molecular profiles with multiple driver alterations/biomarkers that are different from patient to patient. This molecular complexity and heterogeneity require customized treatment regimens targeting multiple driving molecular alterations/biomarkers while ensuring patient safety.
The investigators conducted previously a preliminary trial on optimized personalized-precision oncology. Personalized-precision oncology entails matching patients to the best drug(s) for their tumor - including drug combinations never studied before - at the right doses to the right patients. That study demonstrated that therapy matched to each cancer's complex and unique molecular profile, as suggested by an expert molecular tumor board, is feasible and safe. In addition, the investigators showed that receipt of therapy targeting a higher proportion of molecular alterations/biomarkers in the tumor was strongly associated with longer progression free survival.
The present randomized study aims to expand the previous findings to evaluate efficacy and safety of molecularly matched therapy in metastatic unresectable cancers and to develop innovative machine learning models to better predict optimal treatment for validation in future trials.
- Conditions
- Metastatic Cancer, Unresectable Carcinoma
- Being tested
- Molecularly matched therapy, Standard of care
- Keywords
- Precision medicine, Molecularly matched therapy, Tumor molecular alterations, Molecular Tumor Board
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecularly matched therapyDrug
Molecularly matched therapy, as identified by a molecular tumor board, to match molecular alterations/biomarkers found in the tumor or circulating tumor DNA.
Standard of careDrug
Standard of care therapy for the tumor type.
| Study group | Role | What they receive |
|---|---|---|
| Molecularly matched therapy | Experimental | Molecularly matched therapy based on tumor's molecular profile. Receives: Drug: Molecularly matched therapy |
| Standard of care | Active comparator | Standard of care treatment. Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Duration of time from randomization until objective tumor progression, clinical progression, treatment discontinuation due to inability to tolerate study therapy, or death from any cause.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason K. Sicklick, M.D., University of California, San Diego
- Investigators
- Jason K. Sicklick, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346209
- Sponsor's protocol ID
- 813379
- Acronym
- STRIPe
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sicklick JK, Kato S, Okamura R, Patel H, Nikanjam M, Fanta PT, Hahn ME, De P, Williams C, Guido J, Solomon BM, McKay RR, Krie A, Boles SG, Ross JS, Lee JJ, Leyland-Jones B, Lippman SM, Kurzrock R. Molecular profiling of advanced malignancies guides first-line N-of-1 treatments in the I-PREDICT treatment-naive study. Genome Med. 2021 Oct 4;13(1):155. doi: 10.1186/s13073-021-00969-w.
PubMed 34607609Sicklick JK, Kato S, Okamura R, Schwaederle M, Hahn ME, Williams CB, De P, Krie A, Piccioni DE, Miller VA, Ross JS, Benson A, Webster J, Stephens PJ, Lee JJ, Fanta PT, Lippman SM, Leyland-Jones B, Kurzrock R. Molecular profiling of cancer patients enables personalized combination therapy: the I-PREDICT study. Nat Med. 2019 May;25(5):744-750. doi: 10.1038/s41591-019-0407-5. Epub 2019 Apr 22.
PubMed 31011206Kato S, Kim KH, Lim HJ, Boichard A, Nikanjam M, Weihe E, Kuo DJ, Eskander RN, Goodman A, Galanina N, Fanta PT, Schwab RB, Shatsky R, Plaxe SC, Sharabi A, Stites E, Adashek JJ, Okamura R, Lee S, Lippman SM, Sicklick JK, Kurzrock R. Real-world data from a molecular tumor board demonstrates improved outcomes with a precision N-of-One strategy. Nat Commun. 2020 Oct 2;11(1):4965. doi: 10.1038/s41467-020-18613-3.
PubMed 33009371
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STudy of Real-world Individualized Precision-oncology
- ClinicalTrials.gov ID
- NCT07346209
- Acronym / sponsor ID
- STRIPe / 813379
- Conditions
- Metastatic Cancer, Unresectable Carcinoma
- Keywords
- Precision medicine, Molecularly matched therapy, Tumor molecular alterations, Molecular Tumor Board
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if drugs that are matched to tumor DNA mutations work to treat metastatic solid cancers in adults. The main questions it aims to answer are:
Is tumor worsening delayed for a longer period of time if patients take drugs that match DNA mutations, compared to if they take standard of care drugs?
Researchers will compare drugs matched to tumor DNA mutations to standard of care drugs to see if the matched drugs work better, and to see if tumor worsening can be delayed for longer the more DNA mutations the drugs target.
Participants will:
Take drugs matched to tumor DNA mutations or standard of care drugs based on the regular dosing schedule of the drugs.
Visit the clinic every approximately 2 months for checkups and tumor imaging.
Detailed description
Next generation sequencing and multi-omic technologies have revealed that advanced or metastatic solid cancers often have complex molecular profiles with multiple driver alterations/biomarkers that are different from patient to patient. This molecular complexity and heterogeneity require customized treatment regimens targeting multiple driving molecular alterations/biomarkers while ensuring patient safety.
The investigators conducted previously a preliminary trial on optimized personalized-precision oncology. Personalized-precision oncology entails matching patients to the best drug(s) for their tumor - including drug combinations never studied before - at the right doses to the right patients. That study demonstrated that therapy matched to each cancer's complex and unique molecular profile, as suggested by an expert molecular tumor board, is feasible and safe. In addition, the investigators showed that receipt of therapy targeting a higher proportion of molecular alterations/biomarkers in the tumor was strongly associated with longer progression free survival.
The present randomized study aims to expand the previous findings to evaluate efficacy and safety of molecularly matched therapy in metastatic unresectable cancers and to develop innovative machine learning models to better predict optimal treatment for validation in future trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Molecularly matched therapy | Experimental | Drug: Molecularly matched therapyMolecularly matched therapy based on tumor's molecular profile. |
| Standard of care | Active comparator | Drug: Standard of careStandard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Aged at least 18 years.
- Metastatic or unresectable solid cancers (all) with a 2-year cancer-associated mortality of ≥ 50%, or immediate prior progression free survival < 4 months, or life expectancy between 6 and 16 months as determined at prescreening and/or enrollment due to cancer diagnosis.
- Previous treatment with up to 2 lines of cancer therapy before enrollment.
Key exclusion criteria (16 listed)
- Presence of very high tumor mutational burden as ≥ 20 mutations/megabase.
- Presence of a microsatellite instability-high as defined by the testing laboratory.
- Deficiency of mismatch repair genes: MLH1, MSH2, MSH6, or PMS2.
- Molecular Tumor Board treatment recommendation is a monotherapy with an immune checkpoint inhibitor.
- Molecular Tumor Board treatment recommendation is considered a standard of care regimen per NCCN guidelines (including treatments considered useful in certain circumstances).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecularly matched therapyMolecularly matched therapy, as identified by a molecular tumor board, to match molecular alterations/biomarkers found in the tumor or circulating tumor DNA. | Drug | Molecularly matched therapy |
| Standard of careStandard of care therapy for the tumor type. | Drug | Standard of care |
Primary outcome
Progression free survival
Time frame: 1 year
Duration of time from randomization until objective tumor progression, clinical progression, treatment discontinuation due to inability to tolerate study therapy, or death from any cause.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 34607609Sicklick JK, Kato S, Okamura R, Patel H, Nikanjam M, Fanta PT, Hahn ME, De P, Williams C, Guido J, Solomon BM, McKay RR, Krie A, Boles SG, Ross JS, Lee JJ, Leyland-Jones B, Lippman SM, Kurzrock R. Molecular profiling of advanced malignancies guides first-line N-of-1 treatments in the I-PREDICT treatment-naive study. Genome Med. 2021 Oct 4;13(1):155. doi: 10.1186/s13073-021-00969-w.
- Background: PubMed 31011206Sicklick JK, Kato S, Okamura R, Schwaederle M, Hahn ME, Williams CB, De P, Krie A, Piccioni DE, Miller VA, Ross JS, Benson A, Webster J, Stephens PJ, Lee JJ, Fanta PT, Lippman SM, Leyland-Jones B, Kurzrock R. Molecular profiling of cancer patients enables personalized combination therapy: the I-PREDICT study. Nat Med. 2019 May;25(5):744-750. doi: 10.1038/s41591-019-0407-5. Epub 2019 Apr 22.
- Background: PubMed 33009371Kato S, Kim KH, Lim HJ, Boichard A, Nikanjam M, Weihe E, Kuo DJ, Eskander RN, Goodman A, Galanina N, Fanta PT, Schwab RB, Shatsky R, Plaxe SC, Sharabi A, Stites E, Adashek JJ, Okamura R, Lee S, Lippman SM, Sicklick JK, Kurzrock R. Real-world data from a molecular tumor board demonstrates improved outcomes with a precision N-of-One strategy. Nat Commun. 2020 Oct 2;11(1):4965. doi: 10.1038/s41467-020-18613-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason K. Sicklick, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Molecularly matched therapy in people with Metastatic Cancer and Unresectable Carcinoma, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason K. Sicklick, MD ((858) 822-5354, cancerCTO@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07346209, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.