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A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

NCT ID: NCT05081609

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2029-08-31

Brief Summary

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TransCon IL-2 β/γ is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This is a first-in-human, open-label, Phase 1/2, dose escalation and dose expansion study of TransCon IL-2 β/γ as monotherapy or in combination therapy in adult participants with advanced or metastatic solid tumors. Given the unique PK profile enabled by the TransCon technology, TransCon IL-2 β/γ presents the opportunity to enhance the therapeutic index of current IL-2 therapy.

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Detailed Description

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IL-2 is a key cytokine that directs the immune system through pleiotropic effects mediated by promoting expansion of both cytotoxic effector cells and Tregs. TransCon IL-2 β/γ is designed as a long-acting delivery prodrug of IL-2 β/γ, a potent cytokine signaling molecule, with the potential to improve the safety and efficacy of IL-2.

Conditions

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Advanced Solid Tumor Locally Advanced Solid Tumor Metastatic Solid Tumor Platinum-resistant Ovarian Cancer Post Anti-PD-1 Melanoma 2L+ Cervical Cancer Neoadjuvant Melanoma Neoadjuvant Non-Small Cell Lung Cancer Post Anti-PD-(L)1 Non-Small Cell Lung Cancer Post Anti-PD-(L)1 Small Cell Lung Cancer Third Line or Later (3L+) HER2+ Breast Cancer Second or Third Line (2L/3L) Cervical Cancer Third-line or Later (3L+) Platinum-resistant Ovarian Cancer (PROC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ

TransCon IL-2 β/γ in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab

TransCon IL-2 β/γ with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Pembrolizumab

Intervention Type DRUG

Pembrolizumab will be administered as an intravenous (IV) infusion

Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC Chemo

TransCon IL-2 β/γ using the RP2D with SOC Chemotherapy to evaluate safety/tolerability and anti-tumor activity of the combination

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Chemotherapy drug

Intervention Type DRUG

SOC chemotherapy will be administered as an intravenous (IV) infusion

Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 Agonist

TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D to evaluate safety/tolerability and anti-tumor activity of the combination

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

TransCon TLR7/8 Agonist

Intervention Type DRUG

TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection

Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgery

(Optional Arm): TransCon IL-2 β/γ using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Surgery

Intervention Type PROCEDURE

Surgery will take place 4-6 weeks after last dose of study treatment.

Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed by surgery

TransCon IL-2 β/γ using the RP2D with Pembrolizumab followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Pembrolizumab

Intervention Type DRUG

Pembrolizumab will be administered as an intravenous (IV) infusion

Surgery

Intervention Type PROCEDURE

Surgery will take place 4-6 weeks after last dose of study treatment.

Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgery

TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

TransCon TLR7/8 Agonist

Intervention Type DRUG

TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection

Surgery

Intervention Type PROCEDURE

Surgery will take place 4-6 weeks after last dose of study treatment.

Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo followed by surgery

TransCon IL-2 β/γ using the RP2D with Pembrolizumab and SOC Chemotherapy followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Pembrolizumab

Intervention Type DRUG

Pembrolizumab will be administered as an intravenous (IV) infusion

Chemotherapy drug

Intervention Type DRUG

SOC chemotherapy will be administered as an intravenous (IV) infusion

Surgery

Intervention Type PROCEDURE

Surgery will take place 4-6 weeks after last dose of study treatment.

Part 3 Combination Dose Expansion

TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D with Pembrolizumab

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Pembrolizumab

Intervention Type DRUG

Pembrolizumab will be administered as an intravenous (IV) infusion

Part 3 Combination Dose Expansion: TransCon IL-2 β/γ monotherapy

TransCon IL-2 β/γ monotherapy

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumab

TransCon IL-2 β/γ + trastuzumab

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Trastuzumab

Intervention Type DRUG

Trastuzumab will be administered as an intravenous (IV) infusion

Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1)

TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1)

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Trastuzumab emtansine (T-DM1)

Intervention Type DRUG

Trastuzumab emtansine (T-DM1) will be administered as an intravenous (IV) infusion

Part 4 Combination Dose Optimization

TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D in titrating doses and/or different dose frequencies with Pembrolizumab

Group Type EXPERIMENTAL

TransCon IL-2 β/γ

Intervention Type DRUG

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Pembrolizumab

Intervention Type DRUG

Pembrolizumab will be administered as an intravenous (IV) infusion

Interventions

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TransCon IL-2 β/γ

TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Intervention Type DRUG

Pembrolizumab

Pembrolizumab will be administered as an intravenous (IV) infusion

Intervention Type DRUG

Chemotherapy drug

SOC chemotherapy will be administered as an intravenous (IV) infusion

Intervention Type DRUG

TransCon TLR7/8 Agonist

TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection

Intervention Type DRUG

Surgery

Surgery will take place 4-6 weeks after last dose of study treatment.

Intervention Type PROCEDURE

Trastuzumab

Trastuzumab will be administered as an intravenous (IV) infusion

Intervention Type DRUG

Trastuzumab emtansine (T-DM1)

Trastuzumab emtansine (T-DM1) will be administered as an intravenous (IV) infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age, or country defined local legal age
* Demonstrated adequate organ function at screening
* Life expectancy \>12 weeks as determined by the Investigator
* Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception
* Participants must have histologically confirmed locally advanced, recurrent, or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy), with the exception of the neoadjuvant cohorts
* Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Part 3 and Part 4: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated protein (CTLA-4) antibody must have a washout of at least 4 weeks from the last dose and evidence of disease progression per investigator assessment before Cycle 1 Day 1 (C1D1) with the exception of the neoadjuvant cohorts
* Participants who have previously received an immunotherapy prior to C1D1 must have any immune-related toxicities resolved to ≤Grade 1 or baseline (prior to the immunotherapy) to be eligible, with the exception of participants on well controlled physiologic endocrine replacement
* Part 3: Neoadjuvant cohorts: participants must have completely resectable disease

Exclusion Criteria

* Symptomatic central nervous system metastases and/or carcinomatous meningitis
* Active autoimmune diseases, regardless of need for immunosuppressive treatment, with the exception of participants well controlled on physiologic endocrine replacement
* Any uncontrolled bacterial, fungal, viral, or other infection
* Significant cardiac disease
* A marked clinically significant baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>480 ms) \[CTCAE Grade 1\]) using Fridericia's QT correction formula
* Positive for human immunodeficiency virus (HIV) or has known active hepatitis B or C infection
* Known hypersensitivity to any study treatment(s) used in the specific study part/cohort
* Participants who have been previously treated with IL-2 or IL-2 variants (all participants)
* Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation).
* Vaccination with live, attenuated vaccines within 4 weeks of C1D1
* Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of C1D1
* Part 3: Other active malignancies within the last 2 years
* Women who are breastfeeding or have a positive serum pregnancy test during screening
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascendis Pharma Oncology Division A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Davis Torrejon-Castro

Role: STUDY_DIRECTOR

Medical Monitor

Locations

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Ascendis Pharma Investigational Site

Los Angeles, California, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Los Angeles, California, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Springfield, Illinois, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Louisville, Kentucky, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Boston, Massachusetts, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Morristown, New Jersey, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

New York, New York, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Huntersville, North Carolina, United States

Site Status TERMINATED

Ascendis Pharma Investigational Site

Canton, Ohio, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Cincinnati, Ohio, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Nashville, Tennessee, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Richmond, Virginia, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Adelaide, , Australia

Site Status RECRUITING

Ascendis Pharma Investigational Site

Adelaide, , Australia

Site Status RECRUITING

Ascendis Pharma Investigational Site

Brisbane, , Australia

Site Status RECRUITING

Ascendis Pharma Investigational Site

Frankston, , Australia

Site Status RECRUITING

Ascendis Pharma Investigational Site

Southport, , Australia

Site Status RECRUITING

Ascendis Pharma Investigational Site

Toorak Gardens, , Australia

Site Status TERMINATED

Ascendis Pharma Investigational Site

Waratah, , Australia

Site Status RECRUITING

Ascendis Pharma Investigational Site

Wilrijk, , Belgium

Site Status RECRUITING

Ascendis Pharma Investigational Site

Montreal, , Canada

Site Status WITHDRAWN

Ascendis Pharma Investigational Site

Montreal, , Canada

Site Status RECRUITING

Ascendis Pharma Investigational Site

Toronto, , Canada

Site Status RECRUITING

Ascendis Pharma Investigational Site

Toronto, , Canada

Site Status RECRUITING

Ascendis Pharma Investigational Site

Cuneo, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Florence, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Grosseto, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Lido di Camaiore, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Livorno, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Meldola, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Milan, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Milan, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Modena, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Roma, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Torino, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Turin, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Verona, , Italy

Site Status RECRUITING

Ascendis Pharma Investigational Site

Krakow, , Poland

Site Status RECRUITING

Ascendis Pharma Investigational Site

Poznan, , Poland

Site Status RECRUITING

Ascendis Pharma Investigational Site

Warsaw, , Poland

Site Status RECRUITING

Ascendis Pharma Investigational Site

Singapore, , Singapore

Site Status RECRUITING

Ascendis Pharma Investigational Site

Singapore, , Singapore

Site Status RECRUITING

Ascendis Pharma Investigational Site

Seoul, Songpa-gu, South Korea

Site Status RECRUITING

Ascendis Pharma Investigational Site

Seongnam-si, , South Korea

Site Status RECRUITING

Ascendis Pharma Investigational Site

Seoul, , South Korea

Site Status RECRUITING

Ascendis Pharma Investigational Site

Seoul, , South Korea

Site Status RECRUITING

Ascendis Pharma Investigational Site

Seoul, , South Korea

Site Status RECRUITING

Ascendis Pharma Investigational Site

Seoul, , South Korea

Site Status RECRUITING

Ascendis Pharma Investigational Site

Barcelona, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Barcelona, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Barcelona, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

L'Hospitalet de Llobregat, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Madrid, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Madrid, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Madrid, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Madrid, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Madrid, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Málaga, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Murcia, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Oviedo, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Pamplona, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Seville, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Seville, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Valencia, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Valencia, , Spain

Site Status RECRUITING

Ascendis Pharma Investigational Site

Taipei, , Taiwan

Site Status TERMINATED

Ascendis Pharma Investigational Site

Taipei, , Taiwan

Site Status TERMINATED

Countries

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United States Australia Belgium Canada Italy Poland Singapore South Korea Spain Taiwan

Central Contacts

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Ascendis Oncology Clinical Trials

Role: CONTACT

[email protected]
+1 650-352-8389

Davis Ascendis Oncology Clinical Trials

Role: CONTACT

[email protected]
+1 650-352-8389

References

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Rosen DB, Kvarnhammar AM, Laufer B, Knappe T, Karlsson JJ, Hong E, Lee YC, Thakar D, Zuniga LA, Bang K, Sabharwal SS, Uppal K, Olling JD, Kjaergaard K, Kurpiers T, Schnabel M, Reich D, Glock P, Zettler J, Krusch M, Bernhard A, Heinig S, Konjik V, Wegge T, Hehn Y, Killian S, Viet L, Runz J, Faltinger F, Tabrizi M, Abel KL, Breinholt VM, Singel SM, Sprogoe K, Punnonen J. TransCon IL-2 beta/gamma: a novel long-acting prodrug with sustained release of an IL-2Rbeta/gamma-selective IL-2 variant with improved pharmacokinetics and potent activation of cytotoxic immune cells for the treatment of cancer. J Immunother Cancer. 2022 Jul;10(7):e004991. doi: 10.1136/jitc-2022-004991.

Reference Type DERIVED
PMID: 35817480 (View on PubMed)

Other Identifiers

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ASND0029

Identifier Type: -

Identifier Source: org_study_id

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