## Protocol Section
### Identification Module
**NCT ID:** NCT06428500

**Brief Title:** QTX3046 in Patients With KRAS G12D Mutations

**Official Title:** A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of QTX3046 in Patients With Advanced Solid Tumors With KRAS G12D Mutations

#### Organization Study ID Info
**ID:** QTX3046-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Quanta Therapeutics
### Status Module
#### Completion Date
**Date:** 2027-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Quanta Therapeutics

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.

### Conditions Module

**Conditions:**

- Advanced Solid Tumor

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 240

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** QTX3046 will be administered orally at escalating doses as defined in the protocol based on dose level assignment

**Intervention Names:**

- Drug: QTX3046

**Label:** Part 1a: QTX3046 monotherapy dose escalation

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** QTX3046 will be administered orally at escalating doses as defined in the protocol in combination with intravenous cetuximab based on dose level assignment

**Intervention Names:**

- Drug: QTX3046

- Combination Product: Cetuximab

**Label:** Part 1b: QTX3046 dose escalation in combination with cetuximab

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) based on cohort assignment

**Intervention Names:**

- Drug: QTX3046

**Label:** Part 2: QTX3046 monotherapy dose expansion

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) in combination with intravenous cetuximab based on cohort assignment

**Intervention Names:**

- Drug: QTX3046

- Combination Product: Cetuximab

**Label:** Part 3: QTX3046 dose expansion in combination with cetuximab

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Part 1a: QTX3046 monotherapy dose escalation

- Part 1b: QTX3046 dose escalation in combination with cetuximab

- Part 2: QTX3046 monotherapy dose expansion

- Part 3: QTX3046 dose expansion in combination with cetuximab

**Description:** QTX3046 will be administered at protocol defined dose.

**Name:** QTX3046

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Part 1b: QTX3046 dose escalation in combination with cetuximab

- Part 3: QTX3046 dose expansion in combination with cetuximab

**Description:** Cetuximab will be administered at protocol defined dose.

**Name:** Cetuximab

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** Define as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab.

**Measure:** Number of participants with Treatment-emergent Adverse Events (TEAEs)

**Time Frame:** up to 2 years

**Description:** DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.

**Measure:** Number of participants with Dose Limiting Toxicities (DLTs)

**Time Frame:** up to 21 days

#### Secondary Outcomes

**Description:** Plasma concentration data for QTX3046 will be used to evaluate the area under the plasma concentration-time curve (AUC) of QTX3046

**Measure:** Area under the plasma concentration-time curve (AUC) of QTX3046

**Time Frame:** up to 2 years

**Description:** Plasma concentration data for QTX3046 will be used to evaluate peak plasma concentration (Cmax) of QTX3046

**Measure:** Peak plasma concentration of QTX3046 (Cmax)

**Time Frame:** up to 2 years

**Description:** The ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.

**Measure:** Objective response rate (ORR)

**Time Frame:** up to 2 years

**Description:** Duration of response (DoR) is defined as the time between first evidence of objective response and disease progression (as measured by RECIST 1.1) or death, whichever occurs earlier, in subjects who achieve CR or PR.

**Measure:** Duration of response (DoR)

**Time Frame:** up to 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
* Part 1: Advanced solid tumors with at least one prior systemic therapy.
* Evaluable and measurable disease per RECIST v1.1.
* Part 2 and 3: Measurable disease per RECIST v1.1

Exclusion Criteria:

* Active brain metastasis or carcinomatous meningitis
* Significant cardiovascular disease
* Active infection requiring intravenous (IV) antibiotics
* Prior treatment with a KRAS inhibitor

Other protocol-defined Inclusion/Exclusion Criteria may apply

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinicaltrials@quantatx.com

**Name:** Quanta Therapeutics Clinical Trials

**Phone:** 415-599-3892

**Role:** CONTACT

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M315

- Name: Cetuximab

- Relevance: HIGH

- As Found: Solid

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068818

- Term: Cetuximab

### Misc Info Module

- Version Holder: 2024-05-31
