Brief Summary

This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study, evaluating the safety, tolerability, pharmacokinetic, preliminary anti-tumor activity, and effects on pharmacodynamic markers following administration of SLC-3010 as monotherapy and in combination with gemcitabine, in patients with various advanced solid tumors.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

420

participants targeted

Target at P75+ for phase_1

Timeline

20mo left

Started Dec 2022

Longer than P75 for phase_1

Geographic Reach

3 countries

9 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

Study Progress67%

Dec 2022Jan 2028

First Submitted

Initial submission to the registry

August 23, 2022

Completed

9 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed

4 months until next milestone

Study Start

First participant enrolled

December 21, 2022

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed

1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected

Last Updated

September 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

August 23, 2022

Last Update Submit

September 18, 2023

Conditions

Advanced Solid Tumor

Keywords

IL-2IL-2/anti-IL-2(TCB2) conjugateSLC-3010Immuno-oncology

Outcome Measures

Primary Outcomes (1)

Occurrence of DLTs
Number of participants with DLTs of SLC-3010 treatment
30 days after last dose

Study Arms (2)

Monotherapy

EXPERIMENTAL

SLC-3010 Intravenous infusion over 30 minutes on day 1 of each 21-day cycle

Drug: SLC-3010

Gemcitabine combination

EXPERIMENTAL

SLC-3010 Intravenous infusion over 30 minutes on day 1 of each 21-day cycle Gemcitabine 1000 ㎎/㎡ Intravenous infusion over 30 minutes on day 1 and 8 of each 21-day cycle

Drug: SLC-3010Combination Product: Gemcitabine

Interventions

SLC-3010DRUG

Intravenous (IV) infusion over 30 minutes on day 1 of each 21-day cycle

Gemcitabine combinationMonotherapy

GemcitabineCOMBINATION_PRODUCT

1000 ㎎/㎡ IV infusion over 30 minutes on day 1 and 8 of each 21-day cycle

Gemcitabine combination

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically or cytologically-documented solid tumors that are inoperable locally advanced, metastatic, or recurrent:
Part 1 Dose Escalation: Patients with any solid tumor who have progressed on or are intolerant to standard therapy, for which no standard therapy is available, or who decline standard therapy.

You may not qualify if:

Patients who have at least one measurable lesion, as defined by RECIST v1.1.
Adult male or female patients ≥18 years of age on day of signing the informed consent form (ICF) or follow local regulatory requirement if the legal age for consenting for study participation is more than 18 years.
Patients who are able and willing to provide written informed consent and are willing and able to comply with all study procedures.
Patients with life expectancy of ≥3 months.
Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Patients who demonstrate adequate organ function as defined.
Resolution of any clinically significant toxic effects of prior therapy to Grade 0 or 1 according to the NCI CTCAE v5.0 (exception of alopecia and other AEs that are acceptable in the opinion of the Investigator and after discussion with the Medical Monitor)
Willingness of male and female patients of reproductive potential to observe conventional and effective birth control methods with failure rates of \<1% for the duration of treatment and for 3 months (6 months for female patients administering gemcitabine) following the last dose of study treatment. This must include barrier methods such as condom or diaphragm with spermicidal gel. Women of childbearing potential (WOCBP) are defined as following menarche and who are not postmenopausal (and 2 years of nontherapy-induced amenorrhea or surgically sterile). For male patients with a nonpregnant female partner of childbearing potential and a WOCBP, 1 of the following highly effective birth control methods, with a failure rate of less than 1% per year when used consistently and correctly, is recommended:
Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally
Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant
Intrauterine device
Intrauterine hormone-releasing system
Bilateral tubal occlusion/ligation
Vasectomized partner
Sexual abstinence Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient.
+34 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Selecxinelead

Study Sites (9)

Selecxine Investigator site

Sarasota, Florida, 34232, United States

NOT YET RECRUITING

Selecxine Investigator site

Detroit, Michigan, 48201, United States

RECRUITING

Selecxine Investigator site

Oklahoma City, Oklahoma, 73104, United States

NOT YET RECRUITING

Selecxine Investigator site

Waratah, New South Wales, 2298, Australia

NOT YET RECRUITING

Selecxine Investigator site

Brentwood, Perth, 6153, Australia

NOT YET RECRUITING

Selecxine Investigator site

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

Selecxine Investigator site

Seoul, Seodaemun-gu, 03722, South Korea

RECRUITING

Selecxine Investigator site

Gyeonggi-do, Seongnam-si, 13620, South Korea

NOT YET RECRUITING

Selecxine Investigator site

Seoul, Songpa-gu, 05505, South Korea

RECRUITING

MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Eun-Jihn Roh, M.S., R.Ph.

CONTACT

+82-1833-7931 slc-3010-001@selecxine.com

Karen Yu, M.S.

CONTACT

+82-1833-7931 slc-3010-001@selecxine.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

September 1, 2022

Study Start

December 21, 2022

Primary Completion

February 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

September 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing: Will not share

Locations

KR(4)US(3)AU(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Monotherapy

Gemcitabine combination

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations