A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of NDI 101150 Administered as Monotherapy or in Combination with Pembrolizumab in Patients with Solid Tumors

This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2
dose (RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and
preliminary antitumor activity of NDI-101150 given as monotherapy or in combination with
pembrolizumab in adult patients with advanced solid tumors.

Key Inclusion Criteria:

- Life expectancy of ≥ 12 weeks

- Measurable or non-measurable disease for Dose Escalation; measurable disease using
RECIST v1.1 is required for Dose Expansion

- Recovered from prior therapy to Grade ≤ 1 or return to baseline status (except for
alopecia)

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Patients with adequate bone marrow, kidney and liver function

- Last dose of previous anticancer therapy ≥ 4 weeks prior to first dose of
NDI-101150; includes prior anti-PD-1 or anti-PD-L1 therapy, other anticancer
therapy, radiotherapy, or surgical intervention

- For Dose Escalation Phase Only (Dose Escalation, Monotherapy and Combination
Therapy): Histologically or cytologically confirmed advanced or metastatic solid
tumors for whom no standard therapies are available or refractory to standard
therapy

- For Dose Expansion Phase (Dose Expansion, Monotherapy and Combination Therapy):
Willing to consent to required tumor biopsy(ies). Histologically or cytologically
confirmed advanced or metastatic G/GEJ, NSCLC or RCC for which no standard therapy
is available or are refractory to standard therapy

Key Exclusion Criteria:

- Previous solid organ or hematopoietic cell transplant

- Central nervous system (CNS) malignant disease not previously treated, active
leptomeningeal disease, uncontrolled symptomatic CNS involvement, or CNS malignant
disease requiring steroid or other therapeutic intervention

- Prior anticancer therapy within 2-6 weeks of trial start (depending on nature of
therapy).

- Clinically significant cardiovascular disease

- History of severe hypersensitivity reaction to treatment with monoclonal
antibody(ies) (for combination therapy cohorts only)

- History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis
(including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans,
cryptogenic organizing pneumonia, etc.), or evidence of history of pneumonitis on
chest computed tomography scan in the last 6 months

- Known additional malignancy that is active and/or in progression requiring treatment

- Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function,
unstable pulmonary condition, uncontrolled diabetes, thromboembolic event within the
past 3 months) or any important medical or psychiatric illness or abnormal
laboratory finding

- Unable to discontinue medications that are strong inducers or inhibitors of CYP3A4
and/or CYP2C8

- History of severe irAE that led to permanent discontinuation of prior immunotherapy

- History of recent Grade >/= 3 irAE or any Grade 4 life-threatening irAE, neurologic
or ocular AE of any grade while receiving prior immunotherapy

NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.