Dr. Sam Saibil
Key Inclusion Criteria:
- At least 18 years of age, or country defined local legal age
- Demonstrated adequate organ function at screening
- Life expectancy >12 weeks as determined by the Investigator
- Female and male participants of childbearing potential who are sexually active must
agree to use highly effective methods of contraception
- Participants must have histologically confirmed locally advanced, recurrent, or
metastatic solid tumor malignancies that cannot be treated with curative intent
(surgery or radiotherapy), with the exception of the neoadjuvant cohorts
- Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status 0,
1, or 2
- Part 3 and Part 4: Eastern Cooperative Oncology Group (ECOG) performance status 0 or
1
- Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or
anti-cytotoxic T-lymphocyte-associated protein (CTLA-4) antibody must have a washout
of at least 4 weeks from the last dose and evidence of disease progression per
investigator assessment before Cycle 1 Day 1 (C1D1) with the exception of the
neoadjuvant cohorts
- Participants who have previously received an immunotherapy prior to C1D1 must have
any immune-related toxicities resolved to ≤Grade 1 or baseline (prior to the
immunotherapy) to be eligible, with the exception of participants on well controlled
physiologic endocrine replacement
- Part 3: Neoadjuvant cohorts: participants must have completely resectable disease
Key Exclusion Criteria:
- Symptomatic central nervous system metastases and/or carcinomatous meningitis
- Active autoimmune diseases, regardless of need for immunosuppressive treatment, with
the exception of participants well controlled on physiologic endocrine replacement
- Any uncontrolled bacterial, fungal, viral, or other infection
- Significant cardiac disease
- A marked clinically significant baseline prolongation of QT/QTc interval (e.g.,
repeated demonstration of a QTc interval >480 ms) [CTCAE Grade 1]) using
Fridericia's QT correction formula
- Positive for human immunodeficiency virus (HIV) or has known active hepatitis B or C
infection
- Known hypersensitivity to any study treatment(s) used in the specific study
part/cohort
- Participants who have been previously treated with IL-2 or IL-2 variants (all
participants)
- Systemic immunosuppressive treatment with the exception for patients on
corticosteroid taper (for example, for chronic obstructive pulmonary disease
exacerbation).
- Vaccination with live, attenuated vaccines within 4 weeks of C1D1
- Treatment with any other anti-cancer systemic treatment (approved or
investigational) or radiation therapy within 4 weeks of C1D1
- Part 3: Other active malignancies within the last 2 years
- Women who are breastfeeding or have a positive serum pregnancy test during screening