Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
JTX-8064-101 is a Phase 1/2, open label, dose escalation and dose expansion clinical study to
determine the safety, tolerability, and recommended Phase 2 dose of JTX-8064 alone and in
combination with a PD-1 inhibitor (PD-1i).
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Thoracic Oncology
Enrollment Eligibility
1. Able and willing to participate and comply with all study requirements and provide
signed and dated informed consent prior to initiation of any study procedures;
2. Histologically or cytologically confirmed advanced/metastatic extracranial solid tumor
malignancy.
1. Stages 1 and 2: Subject must have received, have been intolerant to, have been
ineligible for, or have declined all treatment known to confer clinical benefit
with the exception of subjects enrolled in combination cohorts with a PD-1i,
where a PD-1i is approved by the local regulatory agencies
2. Stage 3: This stage may enroll subjects with the following cancers:
• 3L/4L PD-(L)1-naïve, platinum-resistant ovarian cancer
3. Stage 4: This stage may enroll subjects with the following cancers:
- 2L/3L ccRCC. Subjects must have progressed on or after treatment with an
anti-PD-(L)1 agent in their most recent prior line of therapy
- 2L-4L TNBC. Subjects must have progressed on or after treatment with a prior
anti-PD-(L)1 therapy
- 1L, PD-(L)1-naïve, PD-L1+; combined positive score (CPS) ≥ 1% HNSCC
- 3L/4L, PD-(L)1-naïve, platinum-resistant ovarian cancer
- 2L/3L NSCLC; Subjects must have progressed on or after treatment with
platinum-based chemotherapy and an anti-PD-(L)1-containing therapy. The
anti-PD-(L)1 agent must have been a part of the most recent prior line of
therapy. Subjects with EGFR mutations and ALK rearrangements will be
excluded. Subjects with other targetable genomic aberrations for which FDA
approved therapies exist must have received appropriate FDA-approved
targeted therapy
- 2L/3L cSCC; Subjects must have progressed on or after treatment with an
anti-PD-(L)1 agent in their most recent prior line of therapy
- 2L-4L PD-(L)1-naïve UPS and LPS
- 2L/3L HNSCC. Subjects must have progressed on or after treatment with
platinum-based chemotherapy and an anti-PD-(L)1-containing therapy. The
anti-PD-(L)1 agent must have been a part of the most recent prior line of
therapy.
- 2/3L biliary tract cancer (BTC), including intra-and extra-hepatic biliary
duct cancer and cancer of the gallbladder. Subjects must have progressed on
or after gemcitabine/cisplatin (Gem/Cis) and an anti-PD-(L)1 therapy in the
metastatic setting. Must have PD-(L)1 inhibitor resistance. Subjects with
FGFR and IDH1 mutations must have progressed on or after targeted therapies
for these mutations.
3. Measurable disease, according to the RECIST version 1.1, that has objectively
progressed since (or on) previous treatment as assessed by the Investigator;
4. ≥ 18 years of age;
5. Eastern Cooperative Oncology Group performance status 0 or 1;
6. Predicted life expectancy of ≥ 3 months;
7. Have specified laboratory values (obtained ≤ 28 days prior to first dose) in
accordance with the study protocol;
8. For women of childbearing potential (WOCBP): negative serum pregnancy test during the
Screening period and a negative urine pregnancy test up to 24 hours in advance of C1D1
9. WOCBP and males whose partners are WOCBP must agree to use a highly effective method
of birth control throughout their participation and for 5 months following the last
study drug administration.
Exclusion Criteria:
1. Concurrent anticancer treatment, either FDA approved or investigational, for the
cancer being evaluated in this study or for prior malignancies. A past history of
other malignancies is allowed as long as the subject is not receiving treatment other
than hormonal therapy and, in the judgment of the Investigator, is unlikely to have a
recurrence. Of note, concurrent malignancies that do not require treatment and are
clinically stable are allowed
2. Prior infusion of JTX-8064, LILRB2, or ILT4-directed therapy;
3. The therapies listed below within the specified timeframe:
1. Immunotherapy or biologic therapy < 28 days prior to planned C1D1 or 5
half-lives, whichever is shorter
2. Chemotherapy < 21 days prior to planned C1D1, or < 42 days for mitomycin or
nitrosoureas or 5 half-lives, whichever is shorter
3. Targeted small molecule therapy < 14 days or 5 half-lives, whichever is shorter,
prior to planned C1D1
4. Radiation therapy < 21 days prior to planned C1D1. Exception: Limited (e.g., pain
palliation) radiation therapy is allowed prior to and during study drug
administration as long as there are no acute toxicities, any AE due to prior
radiation therapy has recovered to < Grade 2, and the radiation is not
administered to a target lesion
4. Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord
compression not definitively treated with surgery or radiation (brain metastases that
are stable and asymptomatic after prior treatment will be allowed);
5. Women who are pregnant or breastfeeding or who plan to become pregnant/breastfeed
while on study; men who plan to father children during the study
6. Live vaccines ≤ 30 days of C1D1