Clinical Trials

Inclusion Criteria:

- Tumor type:

1. Participants in Part A (dose escalation) must have histologically- or
cytologically-confirmed metastatic or unresectable solid tumor malignancy.
Participants must have relapsed, refractory, or progressive disease, and should
have no appropriate standard therapy available at the time of enrollment in the
judgement of the investigator. Participants must have one of the following tumor
types:

- Colorectal cancer (CRC)

- Gastric carcinoma (GC) (including signet-ring cell histology) and
gastroesophageal junction adenocarcinoma (GEJ)

- Non-small cell lung cancer (NSCLC), squamous or non-squamous histology

- Pancreatic ductal adenocarcinoma (PDAC)

2. For Part B (dose optimization) and Part C (dose expansion):

- Participants must have histologically- or cytologically-confirmed metastatic
or unresectable solid tumor malignancy.

- The tumor types to be enrolled in dose optimization will be identified by
the sponsor from among those specified in dose escalation.

- CRC

- Prior therapy: Participants must have received prior treatment (in 1 or
more lines of therapy) containing fluoropyrimidine, oxaliplatin, and
irinotecan.

- PDAC

- Prior therapy: Participants must have received 1 prior line of therapy
and received no more than 3 prior lines of therapy in the advanced or
metastatic setting.

- GC/GEJ

- Prior therapy: Participants must have received prior platinum and
fluoropyrimidine-based chemotherapy.

- NSCLC - non-squamous/squamous

- Prior therapy: Participants must have received platinum-based therapy.
If eligible and consistent with local standard of care must have
received a PD-1/PD-L1 inhibitor.

- Small cell lung cancer (SCLC)

- Prior therapy: Participants must have received platinum-based therapy
for extensive-stage disease and no more than 3 prior lines of therapy

- Participants enrolled in the following study parts should have a tumor site that is
accessible for biopsy(ies) and agree to biopsy(ies) and/or submission of archival
tissue

1. Dose optimization

2. Disease-specific expansion cohorts

- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

- Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.

Exclusion Criteria:

- Previous exposure to CEACAM5-targeted therapy.

- Prior treatment with an antibody-drug conjugate (ADC) with a camptothecin payload

- History of another malignancy within 3 years before the first dose of study
intervention, or any evidence of residual disease from a previously diagnosed
malignancy.

- Active cerebral/meningeal disease related to the underlying malignancy. Participants
with a history of cerebral/meningeal disease related to the underlying malignancy are
allowed if prior central nervous system disease has been treated and the participant
is clinically stable (defined as not having received steroid treatment for symptoms
related to cerebral/meningeal disease for at least 2 weeks prior to enrollment and
with no ongoing related AEs).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/5/23. Questions regarding updates should be directed to the study team contact.