Clinical trial NCT06549816: A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors
Official title: An Open-label, Phase 1 Study to Investigate the Safety and Pharmacokinetics of SGN-B6A in Chinese Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Carcinoma, Non-Small Cell Lung
Squamous Cell Carcinoma of Head and Neck
Esophageal Squamous Cell Carcinoma
Gastric Adenocarcinoma
Esophageal Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Keywords: NSCL
Lung Neoplasm
Cancer of Ovary
Ovarian Cancer
Colorectal Cancer
Colorectal Tumors
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will look at a drug called sigvotatug vedotin (SGN-B6A) to find out whether it is safe for Chinese participants who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how do Chinese participants' body interact with sigvotatug vedotin.


Eligibility criteria: Inclusion Criteria:

* Subjects must have histologically or cytologically confirmed metastatic or unresectable locally advanced solid malignancy within one of the tumor types listed below.

  * NSCLC
  * HNSCC
  * ESCC
  * GAC
  * EAC
  * GEJ adenocarcinoma
* Subjects must have disease that is relapsed or refractory, or be intolerant to systemic standard-of-care therapies, and in the judgement of the investigator, should have no appropriate standard-of-care therapeutic option. If a standard-of-care therapy is available that has not been administered, the reason that the therapy is not appropriate must be documented.
* Adequate organ function as defined by the baseline laboratory criteria obtained within 7 days prior to SGN-B6A initiation (Cycle 1 Day 1)
* Measurable or non-measurable disease per RECIST v1.1 at baseline.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Exclusion Criteria:

* 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. Exceptions are malignancies with a negligible risk of metastasis or death.
* Participants with any of the following respiratory conditions:

  * Evidence of noninfectious interstitial lung disease (ILD) or pneumonitis that:
  * \* Was previous diagnosed and required systemic steroids, or
  * \* Is currently diagnosed and managed, or
  * \* Is suspected on radiologic imaging at screening
  * Known diffusing capacity of the lung for carbon monoxide (DLCO) \< 50%
  * Any Grade greater than or equal to (≥) 3 pulmonary disease unrelated to underlying malignancy
  * Prior radiation therapy to the lung that is \>30 gray (Gy) within 6 months of the first dose of sigvotatug vedotin.
* Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2
* Uncontrolled diabetes mellitus
* Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:

  * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
  * have no new or enlarging brain metastases, and
  * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.
* Known history or current diagnosis of carcinomatous meningitis
* Previous treatment with an MMAE-containing agent or an agent targeting integrin beta-6
* Prior anticancer therapies:

  * Chemotherapy within 21 days prior to first administration of sigvotatug vedotin
  * Targeted small molecule agents within 14 days or 5 half-lives (whichever is longer) prior to first administration of sigvotatug vedotin
  * Antibody-based anticancer or other investigational antitumor therapy within 28 days prior to first administration of sigvotatug vedotin
  * Focal radiotherapy or major surgery that is not completed 14 days prior to the first dose of sigvotatug vedotin
* Traditional or herbal medicines:

  * Anti-cancer traditional or herbal medicines within 28 days prior to first administration of sigvotatug vedotin
  * Traditional or herbal medicines for other purposes (such as supportive care) within 7 days prior to first administration of sigvotatug vedotin

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
measure: Number of participants with laboratory abnormalities
timeFrame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
measure: Number of participants with dose-limiting toxicities (DLTs)
timeFrame: Up to 28 days
Secondary outcomes:
measure: Pharmacokinetics (PK) of antibody-conjugated monomethyl auristatin E (ac-MMAE) in plasma: Area under the curve (AUC) after a single dose and multiple doses of SGN-B6A
timeFrame: Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)
measure: PK of ac-MMAE in plasma: maximum concentration (Cmax) after a single dose and multiple doses of SGN-B6A
timeFrame: Single dose: Cycle 1 Day 1 (predose, end of infusion [EOI], and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)
measure: PK of ac-MMAE in plasma: time to maximum concentration (Tmax) after a single dose and multiple doses of SGN-B6A
timeFrame: Single dose: Cycle 1 Day 1 (predose, End of Infusion (EOI), and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)
measure: PK of ac-MMAE in plasma: apparent half-life (t1/2) after a single dose and multiple doses of SGN-B6A
timeFrame: Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)
measure: PK of ac-MMAE in plasma: trough concentration (Ctrough) after a single dose and multiple doses of SGN-B6A
timeFrame: Single dose: Cycle 1 Day 15 predose; Multiple dose: Cycle 2 Day 15 predose (Each Cycle is 28 days)
measure: PK of monomethyl auristatin E (MMAE) in plasma - AUC after a single dose and multiple doses of SGN-B6A
timeFrame: Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)
measure: PK of MMAE in plasma: maximum concentration (Cmax) after a single dose and multiple doses of SGN-B6A
timeFrame: Single dose: Cycle 1 Day 1 (predose, end of infusion [EOI], and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)
measure: PK of MMAE in plasma: time to maximum concentration (Tmax) after a single dose and multiple doses of SGN-B6A
timeFrame: Single dose: Cycle 1 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)
measure: PK of MMAE in plasma: apparent half-life (t1/2) after a single dose and multiple doses of SGN-B6A
timeFrame: Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)
measure: PK of MMAE in plasma: trough concentration (Ctrough) after a single dose and multiple doses of SGN-B6A
timeFrame: Single dose: Cycle 1 Day 15 predose; Multiple dose: Cycle 2 Day 15 predose (Each Cycle is 28 days)
measure: Number of participants with antidrug antibodies
timeFrame: From first dose through up to 37 days following last dose of sigvotatug vedotin
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Wuhan City
country: China
facility: Union Hospital Affiliated to Tongji Medical College,Huazhong University of science and Technology
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: