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Trial ID: NCT05270213
A First-In-Human, Phase 1 a/b Dose Escalation and Expansion Study to Evaluate RBS2418 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Unresectable, Recurrent or Metastatic Tumors
1. Be willing and able to provide written informed consent for the study. The subject may
also provide consent for Future biomedical research (FBR). However, the subject may
participate in the main study without participating in FBR.
2. 18 years of age on day of signing informed consent.
3. Male and female subjects with advanced unresectable, recurrent or metastatic tumors
who have received standard of care (SOC) therapy for their advanced/metastatic tumors
and have no other SOC therapy available. Additionally, subjects must have received,
have been intolerant to, have been ineligible for, or have declined all treatment
known to confer significant clinical benefit.
4. Have histologically or cytologically confirmed cancer diagnosis based on pathology
5. Have a predicted life expectancy of greater or equal to 3 months.
6. Have measurable disease based on RECIST 1.1.
7. Have a performance status of 0, 1 or 2 using the ECOG Performance Scale within 14 days
of first dose of study drug.
8. Willing to submit a pre-treatment (archival or fresh-tissue if no archival is
available) and on-treatment tissue sample for intra-tumoral ENPP1 assessment. Subjects
in whom the treating physician deems such biopsy is clinically contraindicated will be
evaluated on a case-by-case basis for enrollment pending Sponsor consultation.
9. Have a negative urine or serum pregnancy test within 72 hours prior to receiving the
first dose of study drug female subjects of childbearing potential who are not
surgically sterilized or postmenopausal). If the urine test is positive, or cannot be
confirmed as negative, a serum pregnancy test will be required.
10. Demonstrate adequate organ function: hematological, renal, hepatic, coagulation
parameters and obtained within 14 days prior to the first study treatment
1. Any approved anti-cancer therapy including chemotherapy, targeted small molecule
therapy or radiation therapy within 2 weeks prior to trial Day 1; or if subject has
not recovered (i.e., Less than or equal to Grade 1 or returned to baseline level) from
adverse events due to a previously administered agent; the following exceptions are
- Palliative radiotherapy for bone metastases or soft tissue lesions should be
completed > 7 days prior to baseline imaging
- Hormone-replacement therapy or oral contraceptives
- Subjects with Grade 2 neuropathy or Grade 2 alopecia
2. Subjects with evidence of rapid progression on prior therapy resulting in rapid
clinical deterioration should be excluded from participation in the trial.
3. Currently participating and receiving trial therapy or has participated in a trial of
an investigational agent and/or has used an investigational device within 28 days
prior to Day 1.
4. Uncontrolled tumor-related pain
5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
6. Malignancies other than indications open for enrollment within 3 years prior to Day 1,
with the exception of those with negligible risk of metastasis or death treated with
expected curative outcome, undergoing active surveillance or treatment-naïve for
7. Treatment with systemic immunomodulating agents (including but not limited to
Interferons (IFNs), Interleukin-2 (IL-2), anti-PD-1/PD-L1 inhibitors, ipilimumab)
within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first
8. History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins.
9. Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in
Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation.
10. Active autoimmune disease that has required systemic treatment in the past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
11. History or any evidence of interstitial lung disease
12. Treatment with systemic immunosuppressive medication within 2 weeks prior to
initiation of study treatment.
13. Active HIV requiring therapy and Uncontrolled HIV*. HIV antibody testing recommended
per investigator's clinical suspicion.
14. Severe infections within 4 weeks prior to enrollment, including, but not limited to,
hospitalization for complications of infection, bacteremia, or the presence of any
active infection requiring systemic therapy.
15. Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 1
16. Received a live, attenuated vaccine within 28 days prior to enrollment/cohort
assignment or anticipation that such a live attenuated vaccine will be required during
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