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Sarcoma, Soft TissuePhase 1NCT05858710

Study of DPPG2-TSL-DOX Combined With Hyperthermia in Soft Tissue Sarcoma

A Phase 1 study testing DPPG2-TSL-DOX and Dexrazoxane in people with Sarcoma, Soft Tissue, run by Thermosome GmbH at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study aims to explore a new therapeutic approach for advanced soft tissue sarcoma (STS) by investigating the safety, tolerability, and maximum tolerated dose (MTD)/highest tolerated dose (HTD) of DPPG2-TSL-DOX combined with regional hyperthermia (RHT) in patients who have been pre-treated with anthracycline, e.g. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma, Soft Tissue
What is being tested?
DPPG2-TSL-DOX and Dexrazoxane
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
2 sitesGermany
Study dates
19 Apr 2023to 28 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age at the time of consent ≥18 years.
  • Patient has provided written informed consent prior to any study-specific procedure.
  • Locally advanced (unresectable) or metastatic STS, including histological sarcoma subtypes treated as STS, for which treatment with DOX monotherapy is appropriate, as confirmed by the investigator.
  • Pretreatment with an anthracycline (including DOX, epirubicin as mono- or combination therapy). Patients who received anthracycline in an adjuvant setting are eligible.
  • Progressive disease not suitable for surgery after
  • only one further line of chemotherapy (including TKI) if the RHT field targets the clinically relevant tumor manifestation/s (e.g., locally advanced or multifocal intraabdominal STS; diffuse metastatic STS in which RHT of a tumor manifestation [e.g., liver] is considered relevant although other systemic metastases are present that do not endanger the patient, as per the judgment of the investigator), or
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  • two or more further lines of chemotherapies (including TKI) for patients with metastatic STS and a tumor manifestation suitable for RHT.
  • All previous oncological treatments must have been completed ≥3 weeks (21 days) prior to the first dose of study treatment, ensuring a sufficient washout period.
  • Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Eisenhauer et al. 2009).
  • Tumor accessible for RHT.
  • Left ventricular ejection fraction (LVEF) >50% (within 28 days prior to enrolment).
  • Adequate hematologic, organ and coagulation function within 14 days prior to enrolment as assessed by local lab:
  • Absolute neutrophil count (ANC) ≥1.5×10^9/L. Granulocyte-colony stimulating factor (G-CSF) cannot be administered within 2 weeks (14 days) prior to enrolment.
  • Platelet count ≥100×10^9/L.
  • Hemoglobin ≥9.0 g/dL. No transfusions are allowed within 2 weeks (14 days) prior to enrolment.
  • Serum creatinine ≤1.5 times upper limit of normal (ULN).
  • Negative dipstick for proteinuria or if proteinuria ≥2+ (equals ≥ 1001 mg/L or 1.001 g/L (Lamb, et al., 2009), then additional 24 h urine collection <1g protein/ 24 h.
  • Total bilirubin within ULN (except for patients with Gilbert's syndrome, who must have a total bilirubin <3 mg/dL).
  • ALT/ AST ≤3.0×ULN; if the liver has tumor involvement, AST and ALT ≤5.0×ULN are acceptable.
  • An adequate coagulation function as defined by international normalized ratio (INR) ≤1.5×ULN or prothrombin time ≤1.5×ULN, and partial thromboplastin time ≤1.5×ULN (unless receiving anticoagulant therapy). Patients receiving phenprocoumon are recommended to switch to low molecular weight heparin and should have achieved stable coagulation status prior to the first dose of study treatment.
  • Tubular excretion rate (TER) by MAG-3-clearance ≥ TERLoLi (TERLoLi = 70% TERNorm).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix 1).
  • If female, must:
  • Be not of child-bearing potential due to surgical sterilization (at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history or menopause.
  • Be a post-menopausal woman, defined as a woman meeting either of the following criteria:
  • spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (for example, oral contraceptives, hormones, gonadotropin-releasing hormone, antiestrogens, selective estrogen receptor modulators [SERMs], or chemotherapy) ii. spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone level >40 mIU/mL.
  • Women of childbearing potential (WOCBP; for a definition see Appendix 2) and men able to father a child must be ready and able to use two medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at screening, during trial participation, and until 6 months after last dose of study treatment. Also, partner of male participants, who is of childbearing potential must use a highly effective method of contraception during the same duration (Please refer to Appendix 2 for methods of highly effective contraception). A list of contraception methods meeting these criteria is provided in the patient information.
  • At least 3 months' life expectancy in the investigator's assessment.

Who cannot join

  • Patients already enrolled in any clinical study involving an investigational product or medical device or have participated within the past 30 days in a clinical trial involving an investigational product or medical device.
  • History of another primary malignancy, with the exception of:
  • curatively treated non-melanomatous skin cancer
  • curatively treated cervical carcinoma in situ
  • non-metastatic prostate cancer, or
  • other primary non-hematologic malignancies that had been treated with curative intent, no known active disease, and no treatment administered during the last 3 years prior to enrolment that the investigator agrees will not affect the interpretation of study results or would be unsuitable for participation in the study.
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  • Active fungal, bacterial and/or known viral infection including human immunodeficiency virus or viral (A, B, or C) hepatitis.
  • Resting heart rate of >100 bpm (measured after ≥10 min. in seated position). Note: If >100 bpm, the measurement should be repeated by up to 3 consecutive measurements at least 10 minutes apart from each other. If all 3 measurements are >100 bpm the exclusion criterion is met.
  • Uncontrolled intercurrent illness including, but not limited to, an ongoing/active infection requiring parenteral antibiotics.
  • Have a serious cardiac condition, such as:
  • unstable angina pectoris
  • angioplasty, cardiac stenting, or myocardial infarction within 6 months of enrolment
  • valvulopathy that is severe, moderate, or deemed clinically significant
  • arrhythmias that are symptomatic or require treatment
  • Have a QTcF interval of >450 msec for males and >470 msec for females on screening electrocardiogram (ECG) utilizing Fridericia's correction.
  • Psychiatric illness or social situation that would limit compliance with study requirements.
  • Any planned or required major surgery during the course of the study.
  • Pregnant or breastfeeding female.
  • Individuals who are institutionalized on a judicial or regulatory order.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Helios Klinikum Berlin-Buch GmbH

    Berlin, 13125

  • Klinikum der Universität München (KUM) Campus Großhadern

    Munich, 81377

Other trials in Germany

About this study

Official title: Phase I Dose Escalation Study of 3-Weekly Intravenous DPPG2-TSL-DOX Combined With Regional Hyperthermia in Locally Advanced or Metastatic Soft Tissue Sarcoma

This study aims to explore a new therapeutic approach for advanced soft tissue sarcoma (STS) by investigating the safety, tolerability, and maximum tolerated dose (MTD)/highest tolerated dose (HTD) of DPPG2-TSL-DOX combined with regional hyperthermia (RHT) in patients who have been pre-treated with anthracycline, e.g. doxorubicin (DOX).

Read the detailed description

Considering that up to 40 percentage of patients with soft tissue sarcoma (STS) will develop metastatic disease and that for these patients overall survival (OS) ranges between 3.7 to 25 months it becomes clear that new therapeutic approaches for the treatment of advanced STS are urgently needed. Doxorubicin (DOX) is a cytotoxic compound that belongs to the class of anthracyclines. DOX has had market authorization since 1960s and is considered the most active chemotherapeutic drug for the treatment of STS. DPPG2-TSL-DOX is a novel formulation of DOX encapsulated in DPPG2-containing thermosensitive liposomes (TSL). Regional hyperthermia (RHT) with a tumor target temperature of ≥41.5 to ≤44 degree of Celsius combined with anthracycline-based chemotherapy has shown to improve survival in patients with localized high-risk STS. Treatment with DPPG2-TSL-DOX aims at combining the confirmed anti-tumor efficacy of anthracyclines in the treatment of locally advanced STS with RHT-triggered DOX release from circulating liposomes resulting in higher local DOX concentrations in the tumor as observed in preclinical studies.

DPPG2-TSL-DOX combined with RHT has been investigated in feline sarcoma at 1 mg/kg dose level resembling the clinically recommended dose level of standard DOX with considerably improved efficacy and better tolerability. The proposed study will characterize the safety and tolerability and, if applicable, the maximum tolerated dose (MTD)/highest tolerated dose (HTD) of DPPG2-TSL-DOX in combination with RHT in patients with advanced or metastatic STS who have been pre-treated with anthracycline. An adapted 3+3 MAD study design with sentinel dosing and a starting dose of 20 mg/m^2 DPPG2-TSL-DOX is applied in this study to identify dose-limiting toxicities (DLTs) of DPPG2-TSL-DOX in combination with RHT.

Being tested
DPPG2-TSL-DOX, Dexrazoxane
Keywords
Sarcoma, Soft Tissue, Doxorubicin/ IV + Liposomes, Doxorubicin
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DPPG2-TSL-DOXDrug

    Also called Doxorubicin, THE001

    DPPG2-TSL-DOX is a thermosensitive liposomal formulation of doxorubicin.

  • DexrazoxaneDrug

    For cardioprotection of participants.

Study groups in NCT05858710
Study groupRoleWhat they receive
IV DPPG2-TSL-DOXExperimentalDPPG2-TSL-DOX (20 or 40 or 50 mg/m^2) + regional hyperthermia (RHT) 3 dose levels are planned in this study: dose level 1 will be receiving 20 mg/m^2 DPPG2-TSL-DOX, dose level 2 will be receiving 40 mg/m^2 DPPG2-TSL-DOX, dose level 3 will be receiving 50 mg/m^2 DPPG2-TSL-DOX. Participants are to be treated with DPPG2-TSL-DOX infusion over 30 minutes and RHT every three weeks (one cycle = 21 days), receiving up to 6 cycles in Main Study Phase and additional 6 cycles in Treatment Continuation Phase, if eligible: * In the first cycle (cycle 1), DPPG2-TSL-DOX application will be performed without RHT in all participants for safety precaution. * In cycles 2-12, DPPG2-TSL-DOX will be applied in parallel with RHT. Dexrazoxane as cardioprotectant will be provided for participants overcoming a cumulative dose of 300 mg/m^2 DOX.
Receives: Drug: DPPG2-TSL-DOX; Drug: Dexrazoxane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD)

    If no more than 1 subject experiencing DLTs is identified after all subjects completed cycle 3 in dose level 3, MTD for the current study and study population will be considered 50 mg/m2.

    Measured: End of study (up to 14 months)

  2. Highest tolerated dose (HTD)

    Highest dose considered safe for dose escalation by the independent DSMB in the FiH study provided < 33% experiencing a DLT per DL are reported in the study until completion or early termination.

    Measured: End of study (up to 14 months)

Secondary outcomes (22)

  1. Adverse Events (AEs)

    Number of treatment-emergent AEs according to CTCAE 5.0

    Measured: End of study (up to 14 months)

  2. Serious Adverse Events (SAEs)

    Number of treatment-emergent SAEs according to CTCAE 5.0

    Measured: End of study (up to 14 months)

  3. Laboratory abnormalities

    Number of laboratory abnormalities

    Measured: End of study (up to 14 months)

  4. Electrocardiogram (ECG) abnormalities

    Number of participants with ECG abnormalities

    Measured: End of study (up to 14 months)

  5. Echocardiogram (ECHO) abnormalities

    Number of participants with ECHO abnormalities

    Measured: End of study (up to 14 months)

  6. Renal toxicities

    Number of participants with renal toxicities

    Measured: End of study (up to 14 months)

  7. Maximum concentration (Cmax) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    without RHT (cycle 1; 12 time points)

    Measured: End of study (upto 14 months)

  8. Last measurable (non-zero) concentration (Clast) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    without RHT (cycle 1; 12 time points)

    Measured: End of study (upto 14 months)

  9. Area under the curve from time 0 to x hours (AUC[0-x] ) after the start of infusion of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    without RHT (cycle 1; 12 time points)

    Measured: End of study (upto 14 months)

  10. Area under the curve from time 0 to the time of the last quantifiable concentration (AUC[0-tlast) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    without RHT (cycle 1; 12 time points)

    Measured: End of study (upto 14 months)

  11. Time of maximum observed concentration (Tmax) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    without RHT (cycle 1; 12 time points)

    Measured: End of study (upto 14 months)

  12. Terminal half-life (T½) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    without RHT (cycle 1; 12 time points)

    Measured: End of study (upto 14 months)

  13. Clearance (CL) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    without RHT (cycle 1; 12 time points)

    Measured: End of study (upto 14 months)

  14. Volume of distribution at steady-state (Vss) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    without RHT (cycle 1; 12 time points)

    Measured: End of study (upto 14 months)

  15. Maximum concentration obtained after administration (Cmax) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    with RHT (cycle 2; 12 time points)

    Measured: End of study (upto 14 months)

  16. Last measurable (non-zero) concentration (Clast) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    with RHT (cycle 2; 12 time points)

    Measured: End of study (upto 14 months)

  17. Area under the curve from time 0 to x hours (AUC[0-x] ) after the start of infusion of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    with RHT (cycle 2; 12 time points)

    Measured: End of study (upto 14 months)

  18. Area under the curve from time 0 to the time of the last quantifiable concentration (AUC[0-tlast) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    with RHT (cycle 2; 12 time points)

    Measured: End of study (upto 14 months)

  19. Time of maximum observed concentration (Tmax) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    with RHT (cycle 2; 12 time points)

    Measured: End of study (upto 14 months)

  20. Terminal half-life (T½) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    with RHT (cycle 2; 12 time points)

    Measured: End of study (upto 14 months)

  21. Clearance (CL) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    with RHT (cycle 2; 12 time points)

    Measured: End of study (upto 14 months)

  22. Volume of distribution at steady-state (Vss) of DPPG2, non-liposomal DOX, liposomal encapsulated DOX and total DOX

    with RHT (cycle 2; 12 time points)

    Measured: End of study (upto 14 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2023
  2. Study start19 Apr 2023
  3. Primary completion30 Jan 2025
  4. Study completion28 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
an adapted 3+3 multiple ascending dose (MAD) design with sentinel dosing
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05858710
Sponsor's protocol ID
TS-DM-STS-101
Other IDs
2023-507836-19-00, 2020-005033-32, 2023
Status last verified
Jul 2025
First submitted
24 Apr 2023
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DPPG2-TSL-DOX and Dexrazoxane in people with Sarcoma, Soft Tissue, run by Thermosome GmbH at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: End of study (up to 14 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05858710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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