Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Head and Neck Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Antibodies

Immunoglobulins

Additional enrollment into previously cleared monotherapy dose levels

Dose escalation and determination in selected tumor types

CX-2009

Monika Vainorius, MD

The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001

PROBODY is a trademark of CytomX Therapeutics, Inc

PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors

A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)

All AEs will be captured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 and considered for assessment of DLTs as outlined by the criteria in Protocol Table 5.

Efficacy will be assessed via objective response rate (ORR) by RECIST version 1.1. ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) on two consecutive tumor assessments with scan dates at least 4 weeks apart according to RECIST (version 1.1, refer to SAP section 13.1.1). Complete criteria for RECIST 1.1 are provided as an appendix to the protocol.

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\> For as long as a subject continues follow-up for response in the study, CT/MRI/Tumor assessment are to be conducted every 8 (+/- 1) weeks from the first dose of CX 2009 with assessment for response per

\> RECIST Version 1.1

CytomX Therapeutics

Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable).

Output for the all-cause mortality table includes deaths secondary to progression of disease.

Part A 0.25 mg/kg Q3W

Part A 0.5 mg/kg Q3W

Part A 1 mg/kg Q3W

Part A 2 mg/kg Q3W

Parts A & A2 4 mg/kgQ3W (4 in Part A, 6 inPart A2)

Parts A & A2 5 mg/kgQ3W (3 in Part A, 6 inPart A2)

Parts A & A2 6 mg/kgQ3W (3 in Part A, 6 inPart A2)

Parts A, A2 & B 7mg/kg Q3W (3 in PartA, 6 in Part A2, 3 inPart B)

Parts A & A2 8 mg/kgQ3W (16 in Part A, 6 inPart A2)

Parts A & A2 9 mg/kgQ3W (3 in Part A, 6 inPart A2)

Parts A & A2 10 mg/kgQ3W (5 in Part A, 3 inPart A2)

Part C1 4 mg/kg Q2W

Part C1 6 mg/kg Q2W

A 0.25 mg/kg Q3W

A 0.5 mg/kg Q3W

A 1 mg/kg Q3W

A 2 mg/kg Q3W

A, A2 4 mg/kg Q3W

A, A2 5 mg/kg Q3W

A, A2 6 mg/kg Q3W

A, A2 7 mg/kg Q3W

A, A2 8 mg/kg Q3W

A, A2 9 mg/kg Q3W

A, A2 10 mg/kg Q3W

C1 4 mg/kg Q2W

C1 6 mg/kg Q2W

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Summaries are presented by dose and schedule. Specifically, all available data from Parts A, A2, and B is pooled by dose group; Part C1 dosing 4 mg/kg Q2W and 6 mg/kg Q2W are also presented by dose and schedule.

This study was terminated early due to the Covid Pandemic and the company's business decision to separate the Phase 2 (part B) course of the study to a separate, new Phase 2 study. The Phase 1 (part A) course of the study was completed and the RP2D was determined. Part B only enrolled 3 patients and the Secondary and other Outcomes were not analyzed.

Monika Vainorius

Participants not experiencing DLTs

Participants experiencing DLT

A, A2, B 7 mg/kg Q3W

A DLT-evaluable subject is defined as one having received at least 1 dose of CX-2009 (or CX 2009 and CX-072) and then having completed the full DLT observation period (either 21 or 28 days depending on the schedule), or one who subsequently withdrew due to a drug-related toxicity.

The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy

A 0.25 Q3W

The response evaluable population includes all subjects in the safety analysis population who have an adequate baseline disease assessment and at least one post-baseline disease assessment.

Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy

Study Discontinuation--Treatment Period

Study Discontinuation--Follow-Up Period

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors	NCT03149549	Solid Tumor, Ad... Breast Cancer Non Small Cell ... Head and Neck C... Ovarian Cancer	CX-2009	18 Years -	CytomX Therapeutics
PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors	NCT03149549	Solid Tumor, Ad... Breast Cancer Non Small Cell ... Head and Neck C... Ovarian Cancer	CX-2009	18 Years -	CytomX Therapeutics

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