Brief Title: A Study of GEN1106 in Participants With Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Part 1 Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)

Primary Outcome 1 - Timeframe: 21 days

Primary Outcome 2 - Measure: Part 1 Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Primary Outcome 2 - Timeframe: Up to approximately 16 months

Primary Outcome 3 - Measure: Part 2 Dose Refinement: Number of Participants with AEs and SAEs

Primary Outcome 3 - Timeframe: Up to approximately 16 months

Primary Outcome 4 - Measure: Part 3 Expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Primary Outcome 4 - Timeframe: Up to approximately 16 months

CONDITION

• Solid Tumors
• Urothelial Carcinoma

ELIGIBILITY

Key Inclusion Criteria:
* Have progressed on or after standard of care (SoC) therapy, which should include chemotherapy, anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapies, and enfortumab vedotin (EV), if applicable for the tumor type, or for whom there is no available standard therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1106 may be beneficial, in the opinion of the investigator.

- * Have measurable disease according to RECIST v1.1.

- * Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening.

- * Part 1: Have histologically or cytologically confirmed diagnosis of cancer as specified per protocol.

- * Parts 2 and 3: Have histologically or cytologically confirmed diagnosis of metastatic urothelial carcinoma (mUC).
Key Exclusion Criteria:
* Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) therapy.

- * Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.

- * Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or lower, except for alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to grade 2.
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Study Official

Role: Study Director

Affiliation: Genmab

Overall Contact

Name: Genmab Trial Information

Phone: +4570202728

Email: [email protected]

LOCATION