Phase
Condition
Neoplasms
Treatment
NPX887
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed recurrent, metastatic solid tumorrefractory to, or intolerant of, standard of care therapy in one of the followingindications:
Phase 1a (Dose Escalation): Non-small cell lung carcinoma (NSCLC), small celllung carcinoma (SCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC),gastric and gastro-esophageal carcinoma, esophageal adenocarcinoma, biliarytract cancers, ovarian carcinoma, and other solid tumor types known to expressB7-H7/HHLA2.
Phase 1b including Part 1b (Dose Expansion) and Part 1c (Randomized DoseComparison): participants who have clear cell RCC, EGFR mutant lungadenocarcinoma, or gastric/GEJ adenocarcinoma.
In Phase 1b, participants must have confirmed B7-H7/HHLA2 expression in theirtumor determined via archival tissue IHC testing through a central lab (pre-screening).
Phase 1a: Evaluable disease (measurable or non-measurable) by RECIST v.1.1 criteria;Phase 1b: Measurable disease by RECIST v1.1 criteria with additionaldisease-specific enrollment criteria applied to clear cell RCC, EGFR mutant lungadenocarcinoma, or gastric/GEJ adenocarcinoma.
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
Ability to understand and the willingness to sign a written informed consentdocument
Willing to use highly effective contraceptive measures throughout the trial.
Exclusion
Exclusion Criteria:
Treatment with any of the following:
Systemic anticancer treatment ≤14 days or within 5 half-lives prior to thefirst dose of study drug, whichever is shorter.
Limited-field radiotherapy ≤7 days or extended-field thoracic radiotherapy ≤8weeks of the first dose of study drug.
Have any unresolved toxicity of ≥Grade 2 from previous anti-cancer treatment, exceptfor alopecia, chronic stable neuropathy for >4 months, changes in skin pigmentation,or requiring replacement therapy for endocrine abnormalities.
Participants with known brain metastases are excluded unless they are clinicallystable, with no new or enlarging brain metastases as evidenced on MRI duringscreening.
History of Grade 3 immune-related pneumonitis or colitis.
Participants who discontinued prior immunotherapy due to immune-related toxicities,or history of unresolved prior immune-related toxicity except for endocrineabnormalities requiring replacement therapy or vitiligo.
Known autoimmune disease requiring immunosuppressive treatment requiring theequivalent of more than 10 mg prednisone daily.
Study Design
Study Description
Connect with a study center
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
Johns Hopkins University
Baltimore, Maryland 21287
United StatesActive - Recruiting
Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United StatesSite Not Available
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts 02215
United StatesSite Not Available
Albert Einstein Medical College Montefiore Medical Center
Bronx, New York 10461
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Next Oncology
San Antonio, Texas 78229
United StatesSite Not Available
NEXT Oncology-Fairfax
Fairfax, Virginia 22031
United StatesSite Not Available

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