Advanced Solid TumorsPhase 1/2NCT03993678
Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors.
A Phase 1/2 study testing IP-001 and Thermal Ablation in people with Advanced Solid Tumors, run by Swiss Cancer Institute at 3 sites in Switzerland.
Trial summary
The therapeutic approach taken by trial SAKK 66/17 is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- IP-001 and Thermal Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 12 Oct 2020to 19 Jul 2025
- Phase
- Phase 1/2
- 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
- Written informed consent according to Swiss law and ICH/GCP regulations before registration.
- Part 1: - 'All comer' Patients with either histologically or cytologically confirmed advanced or recurrent solid tumor cancer who failed standard therapy, are not eligible for standard therapy, or for whom no effective standard therapy is available and not requiring fast responses.
- Part 2, Cohort 1 - Sarcoma cohort: Patients with either histologically or cytologically confirmed advanced or recurrent soft tissue sarcoma who failed standard therapy, are not eligible for standard therapy or for whom no effective standard therapy is available.
- Part 2, Cohort 2 - Melanoma cohort: Patients with either histologically or cytologically confirmed advanced or recurrent melanoma who failed standard therapy (including a BRAF inhibitor for BRAF-mutant patients), are not eligible for standard therapy or for whom no effective standard therapy is available and have LDH < ULN.
- Presence of at least one tumor lesion that is laser ablation-accessible, with a minimum size of 1.0 cm and located (typically subcutaneously) that it can be treated with Ablation + IP-001 without risk of skin necrosis or serious damage to other adjacent vital and healthy tissue. This tumor lesion may either belong to the skin, lymph nodes, muscles or subcutaneous tissue.
- Measurable or evaluable disease, determined with the most suitable imaging method (CT, PET-CT or MRI), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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- No evidence of CNS progression for at least 4 weeks after completion of CNS-directed therapy as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
- Age ≥ 18 years
- WHO performance status 0-2
- Bone marrow function: neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 90 g/L
- Hepatic function: bilirubin ≤ 1.5 x ULN, aspartate transaminase (AST) and alanine transaminase ALT ≤ 2.5 x ULN (or ≤ 5 x ULN in presence of liver metastasis)
- Renal function: estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73m2 (according to Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) formula)
- Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and for an additional 90 days after the last dose of investigational drug. Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test before inclusion.
- Men agree not to donate sperm or to father a child during trial treatment and until 90 days after the last dose of investigational drug.
Who cannot join
- Malignant primary brain tumors, or clinically unstable symptoms from brain metastases or leptomeningeal disease, indicative of active disease.
- Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days (7 days for single fraction of palliative radiotherapy, 42 days for nitrosoureas or mitomycin C) prior to registration.
- Patients who have not recovered to ≤ CTCAE grade 1 from all side effects of prior therapies except for residual toxicities, such as alopecia, which do not pose an ongoing medical risk.
- Patients with a previously treated malignancy, when the risk of the prior malignancy interfering with either safety or efficacy endpoints is not very low.
- Patients with prostate cancer must have discontinued anti-androgens (e.g., bicalutamide, nilutamide) for at least 6 weeks prior to registration; chemical castration with luteinizing hormone-releasing hormone analogues must be continued or patients must be surgically castrated.
- Concomitant treatment with systemic corticosteroids (daily dose of 10 mg prednisolone or equivalent is allowed) or other immunosuppressive therapy (e.g. methotrexate).
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- Oral anti-coagulation with vitamin K antagonists (e.g. phenprocoumon, warfarin) and heparin, including therapeutically dosed low molecular weight heparins (LMWH) which cannot be stopped 24 hours prior to trial treatment (low dose aspirin allowed) and bleeding diathesis
- Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classificationIII or IV), unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension .
- Known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B Viral infection or any uncontrolled active systemic infection (> CTCAE grade 2) requiring intravenous (iv) antimicrobial treatment
- Serious autoimmune disease (e.g. systemic lupus erythematodes) which is judged to reduce an anti-tumor immune response.
- Known allergic reaction to shellfish, crabs, crustaceans, or any trial components, including medical device, used in trial treatment.
- Any other serious underlying medical, psychological, familial or geographical condition, which in the judgment of the investigator may limit compliance with the planned staging, treatment and follow-up, or place the patient at high risk from treatment-related complications.
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Inselspital, Bern
Bern, CH-3010
Kantonsspital Graubünden
Chur, 7000
Kantonsspital St. Gallen
Sankt Gallen, CH-9007
About this study
Official title: Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. A Multicenter Phase Ib/IIa Trial With Expansion Cohorts in Melanoma and Soft Tissue Sarcoma Patients.
The therapeutic approach taken by trial SAKK 66/17 is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy.
Patients with laser ablation-accessible solid tumors are treated by thermal ablation followed immediately by an intratumoral injection of IP-001 (1 % N-dihydro-galacto-chitosan, Immunophotonics Inc.) for injection). IP-001 is intended to trigger a tumor-specific systemic immune response when exposed to tumor antigens liberated by thermal ablation. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 might be able to turn 'cold' tumors into 'hot' tumors, inducing a systemic immune response. This may result in shrinkage of the treated tumor, as well as, long-term response mediated by the patient's immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells) including tumor cells outside or distant from the treated area (also known as abscopal effect).
Read more
This trial will provide information on the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in patients with laser ablation-accessible solid tumors ('all comers', Part 1 - safety run in). Further information on safety and tolerability, as well as preliminary antitumor activity, will be evaluated in patients with soft tissue sarcoma (Part 2, Cohort1), whereas in melanoma patients, anti-tumor activity will be defined as a primary objective (Part 2, Cohort 2).
The trial treatment consists of an Ablation + IP-001 in 4-week intervals for up to 6 scheduled treatments. Thermal ablation will be performed according to the instruction of the medical device, and IP-001 will be administered in different dose levels according to the trial design. All patients will be followed until progression of disease or until the start of a subsequent treatment.
Read the detailed description
Despite constant progress in the treatment of patients with advanced solid tumors failing standard systemic treatment, there is still a high unmet medical need to develop new active anticancer drugs or therapies. Although patients with advanced melanoma have benefitted substantially from the new checkpoint inhibitors, monoclonal antibodies, etc., those patients progressing after such treatment are still in high need of additional treatment options. In the field of advanced sarcoma, little to no progress has been made in the last years, and chemotherapy is still standard treatment for these patients. The therapeutic approach taken by trial SAKK 66/17 is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 (1 % N-dihydro-galacto-chitosan, Immunophotonics Inc.) for injection) might be able to turn 'cold' tumors into 'hot' tumors, inducing a systemic immune response. This may result in shrinkage of the treated tumor, as well as long-term response mediated by the patient's immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells), including tumor cells outside or distant from the treated area (also known as abscopal effect).
The primary objective of Part 1 is to determine the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in patients with laser ablation-accessible solid tumors ('all comers').
The primary objective of Part 2 - Cohort 1 (soft tissue sarcoma, STS) is to further determine the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in the dose established in Part 1 of the trial.
The primary objective of Part 2 - Cohort 2 (melanoma) of the trial is to define anti-tumor activity of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) utilizing the dose established in Part 1 of the trial.
The secondary objective of the trial is
- to further determine the safety and tolerability of IP-001 (Part 2, Cohort 1 and 2)
- to assess the preliminary anti-tumor activity in STS patients (Part 2, Cohort 1)
- to observe further signs of clinical preliminary anti-tumor activity in patients with melanoma (Part 2, Cohort 2).
- Conditions
- Advanced Solid Tumors
- Being tested
- IP-001, Thermal Ablation
- Keywords
- advanced solid tumors, Intratumoral injection, IP-001, thermal ablation, phase Ib/IIa, melanoma, soft tissue sarcoma, tumor ablation, systemic immune response, interventional immuno-oncology, abscopal effect, T cell stimulation
- Medical subject headings
- Melanoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP-001Drug
Dose and route: Immediately (within 15 - 30 min) after thermal ablation, IP-001 will be injected in and around the ablated lesion. The amount of IP-001 injected depends on the dose level.
Thermal AblationDevice
Also called TRANBERG Thermal Therapy System®, Thermal Therapy System (Clinical Laserthermia Systems AB)
The medical device includes a laser unit. The system continuously measures the temperature of the tissue, guiding the user to perform precise and safe treatments.
Treatment time: 30 min
| Study group | Role | What they receive |
|---|---|---|
| Ablation + IP-001 | Experimental | Ablation + IP-001 will be administered every 4 weeks for up to 6 treatment visits.
Trial treatment will stop in case of tumor progression according to RECIST 1.1 or iRECIST or unacceptable toxicity.
In all cases, toxicity assessment will continue for at least 100 days after discontinuing the last treatment of Ablation + IP-001 or until resolution of Ablation + IP-001-associated toxicity. Receives: Drug: IP-001; Device: Thermal Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and Part 2, cohort 1 (expansion cohort - STS): Dose-limiting toxicity (DLT)
The primary endpoint is the frequency of DLTs which are relevant for the determination the tentative RP2D in Part 1 of the trial.
Measured: Day 1 to day 28
Part 2, Cohort 2 (phase IIa - melanoma): Disease control (DC) according to RECIST 1.1
DC is defined as any complete response (CR), partial response (PR) or stable disease (SD) for 12 weeks from start of treatment according to RECIST 1.1 criteria achieved during trial treatment. Any patient with CR, PR or SD (≥ 12 weeks) as best observed response during trial treatment will be considered as a success; otherwise they will be considered as a failure.
Patients without any response assessment during trial treatment will be regarded as having a non-evaluable response (NE) and thus will be considered as failures for this endpoint.
Measured: up to 12 weeks from treatment start
Secondary outcomes (8)
Objective response according to iRECIST (iOR)
iOR is defined as any complete response (CR/iCR) or partial response (PR/iPR) according to RECIST 1.1 or iRECIST criteria achieved during trial treatment until disease progression according to iRECIST, death or subsequent anticancer treatment, whichever occurs first. Any patient with CR/iCR or PR/iPR as best observed response during trial treatment until disease progression according to iRECIST, death or subsequent anticancer treatment (whichever occurs first) will be considered as a success; otherwise they will be considered as a failure.
Patients without any objective response assessment during trial treatment until disease progression according to iRECIST, death or subsequent anticancer treatment (whichever occurs first) will be regarded as having a NE and thus will be considered as failures for this endpoint.
Measured: up to 12 weeks from treatment start
Disease control according to iRECIST (iDC)
iDC is defined as any complete response (CR/iCR), partial response (PR/iPR) or stable disease (SD/iSD) for 12 weeks according to RECIST 1.1 or iRECIST criteria achieved during trial treatment until disease progression according to iRECIST, death or start of a subsequent anticancer treatment, whichever occurs first. Any patient with CR/iCR, PR/iPR or SD/iSD (≥12 weeks) as best observed response during trial treatment until disease progression according to iRECIST, death or start of a subsequent anticancer treatment (whichever occurs first) will be considered as a success; otherwise they will be considered as a failure.
Patients without any response assessment during trial treatment until disease progression according to iRECIST, death or start of a subsequent anticancer treatment (whichever occurs first) will be regarded as having a NE and thus will be considered as failures for this endpoint.
Measured: up to 12 weeks from treatment start
Duration of response according to iRECIST (iDoR)
iDoR is defined as the time from the first documentation of iOR until disease progression according to iRECIST criteria (iPD) or death due to disease progression.
iPD is defined as the time point of first iUPD without subsequent iSD, iPR or iCR before trial treatment discontinuation.
Patients not experiencing an event at the time of the analysis, as well as patients starting a subsequent anticancer treatment in the absence of an event, will be censored at the date of their last available tumor assessment showing no evidence of iPD before starting a subsequent anticancer treatment, if any.
Measured: from date of response until date of disease progression according to iRECIST or death due to disease progression, whichever occurs first, assessed up to 4 years
Progression-free survival according to iRECIST (iPFS)
iPFS is defined as the time from treatment start until disease progression according to iRECIST criteria (iPD) or death due to any reason, whichever occurs first.
iPD is defined as the time point of first iUPD without subsequent iSD, iPR or iCR before trial treatment discontinuation.
Patients not experiencing an event at the time of the analysis, as well as patients starting a subsequent anticancer treatment in the absence of an event, will be censored at the date of their last available tumor assessment before starting a subsequent anticancer treatment, if any.
Measured: from treatment start until date of disease progression according to iRECIST or death due to any reason, whichever occurs first, assessed up to 4 years
Objective response (OR) according to RECIST 1.1
OR is defined as any complete response (CR) or partial response (PR) according to RECIST 1.1 criteria achieved during trial treatment. Any patient with CR or PR as best observed response during trial treatment will be considered as a success; otherwise they will be considered as a failure.
Patients without any objective response assessment during trial treatment will be regarded as having a NE and thus will be considered as failures for this endpoint.
Measured: up to 24 weeks from treatment start
Disease control (DC) according to RECIST 1.1 (only for Part 2, Cohort 1)
DC is defined as any complete response (CR), partial response (PR) or stable disease (SD) for 12 weeks from registration according to RECIST 1.1 criteria achieved during trial treatment. Any patient with CR, PR or SD (≥ 12 weeks) as best observed response during trial treatment will be considered as a success; otherwise they will be considered as a failure.
Patients without any response assessment during trial treatment will be regarded as having a NE and thus will be considered as failures for this endpoint.
Measured: up to 24 weeks from treatment start
Duration of response (DoR) according to RECIST 1.1
DoR is defined as the time from the first documentation of OR until disease progression according to RECIST 1.1 criteria or death due to disease progression, whichever occurs first.
Patients not experiencing an event at the time of the analysis, as well as patients starting a subsequent anticancer treatment in the absence of an event, will be censored at the date of their last available tumor assessment before starting a subsequent anticancer treatment, if any.
Measured: from date of response until date of disease progression according to RECIST 1.1 or death due to disease progression, whichever occurs first, assessed up to 4 years
Progression-free survival (PFS) according to RECIST 1.1
PFS is defined as the time from treatment start until disease progression according to RECIST 1.1 criteria or death due to any reason, whichever occurs first.
Patients not experiencing an event at the time of the analysis, as well as patients starting a subsequent anticancer treatment in the absence of an event, will be censored at the date of their last available tumor assessment before starting a subsequent anticancer treatment, if any.
Measured: from treatment start until date of disease progression according to RECIST 1.1 or death due to any reason, whichever occurs first, assessed up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start12 Oct 2020
- Primary completion15 Jul 2025
- Study completion19 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter single arm, phase Ib/IIa with 2 Parts: * Part 1 (referring to the phase Ib part of the trial) consists of a safety run-in cohort with 1 dose level (DL) of IP-001 and a de-escalation safety step with a reduced dose of IP-001, if needed. This 'all-comers' cohort will enroll patients with laser ablation-accessible advanced solid tumors. * Part 2 * Cohort 1: Dose expansion cohort consisting of 9 patients with advanced STS treated at the tentative recommended phase 2 dose (RP2D), as established in Part 1; * Cohort 2: Phase IIa part consisting of 18 patients with advanced melanoma treated at the tentative RP2D, as established in Part 1.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Immunophotonics, Inc.
- Responsible party
- Sponsor
- Investigators
- Markus Joerger, MD PhD, Study chair, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993678
- Sponsor's protocol ID
- SAKK 66/17
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2019
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. A Multicenter Phase Ib/IIa Trial With Expansion Cohorts in Melanoma and Soft Tissue Sarcoma Patients.
- ClinicalTrials.gov ID
- NCT03993678
- Acronym / sponsor ID
- SAKK 66/17
- Conditions
- Advanced Solid Tumors
- Keywords
- advanced solid tumors, Intratumoral injection, IP-001, thermal ablation, phase Ib/IIa, melanoma, soft tissue sarcoma, tumor ablation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Collaborators
- Immunophotonics, Inc.
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 19 Jul 2025 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The therapeutic approach taken by trial SAKK 66/17 is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy.
Patients with laser ablation-accessible solid tumors are treated by thermal ablation followed immediately by an intratumoral injection of IP-001 (1 % N-dihydro-galacto-chitosan, Immunophotonics Inc.) for injection). IP-001 is intended to trigger a tumor-specific systemic immune response when exposed to tumor antigens liberated by thermal ablation. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 might be able to turn 'cold' tumors into 'hot' tumors, inducing a systemic immune response. This may result in shrinkage of the treated tumor, as well as, long-term response mediated by the patient's immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells) including tumor cells outside or distant from the treated area (also known as abscopal effect).
This trial will provide information on the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in patients with laser ablation-accessible solid tumors ('all comers', Part 1 - safety run in). Further information on safety and tolerability, as well as preliminary antitumor activity, will be evaluated in patients with soft tissue sarcoma (Part 2, Cohort1), whereas in melanoma patients, anti-tumor activity will be defined as a primary objective (Part 2, Cohort 2).
The trial treatment consists of an Ablation + IP-001 in 4-week intervals for up to 6 scheduled treatments. Thermal ablation will be performed according to the instruction of the medical device, and IP-001 will be administered in different dose levels according to the trial design. All patients will be followed until progression of disease or until the start of a subsequent treatment.
Detailed description
Despite constant progress in the treatment of patients with advanced solid tumors failing standard systemic treatment, there is still a high unmet medical need to develop new active anticancer drugs or therapies. Although patients with advanced melanoma have benefitted substantially from the new checkpoint inhibitors, monoclonal antibodies, etc., those patients progressing after such treatment are still in high need of additional treatment options. In the field of advanced sarcoma, little to no progress has been made in the last years, and chemotherapy is still standard treatment for these patients. The therapeutic approach taken by trial SAKK 66/17 is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 (1 % N-dihydro-galacto-chitosan, Immunophotonics Inc.) for injection) might be able to turn 'cold' tumors into 'hot' tumors, inducing a systemic immune response. This may result in shrinkage of the treated tumor, as well as long-term response mediated by the patient's immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells), including tumor cells outside or distant from the treated area (also known as abscopal effect).
The primary objective of Part 1 is to determine the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in patients with laser ablation-accessible solid tumors ('all comers').
The primary objective of Part 2 - Cohort 1 (soft tissue sarcoma, STS) is to further determine the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in the dose established in Part 1 of the trial.
The primary objective of Part 2 - Cohort 2 (melanoma) of the trial is to define anti-tumor activity of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) utilizing the dose established in Part 1 of the trial.
The secondary objective of the trial is
- to further determine the safety and tolerability of IP-001 (Part 2, Cohort 1 and 2)
- to assess the preliminary anti-tumor activity in STS patients (Part 2, Cohort 1)
- to observe further signs of clinical preliminary anti-tumor activity in patients with melanoma (Part 2, Cohort 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter single arm, phase Ib/IIa with 2 Parts: * Part 1 (referring to the phase Ib part of the trial) consists of a safety run-in cohort with 1 dose level (DL) of IP-001 and a de-escalation safety step with a reduced dose of IP-001, if needed. This 'all-comers' cohort will enroll patients with laser ablation-accessible advanced solid tumors. * Part 2 * Cohort 1: Dose expansion cohort consisting of 9 patients with advanced STS treated at the tentative recommended phase 2 dose (RP2D), as established in Part 1; * Cohort 2: Phase IIa part consisting of 18 patients with advanced melanoma treated at the tentative RP2D, as established in Part 1.
| Arm | Type | Receives |
|---|---|---|
| Ablation + IP-001 | Experimental | Drug: IP-001, Device: Thermal AblationAblation + IP-001 will be administered every 4 weeks for up to 6 treatment visits. Trial treatment will stop in case of tumor progression according to RECIST 1.1 or iRECIST or unacceptable toxicity. In all cases, toxicity assessment will continue for at least 100 days after discontinuing the last treatment of Ablation + IP-001 or until resolution of Ablation + IP-001-associated toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent according to Swiss law and ICH/GCP regulations before registration.
- Part 1: - 'All comer' Patients with either histologically or cytologically confirmed advanced or recurrent solid tumor cancer who failed standard therapy, are not eligible for standard therapy, or for whom no effective standard therapy is available and not requiring fast responses.
- Part 2, Cohort 1 - Sarcoma cohort: Patients with either histologically or cytologically confirmed advanced or recurrent soft tissue sarcoma who failed standard therapy, are not eligible for standard therapy or for whom no effective standard therapy is available.
- Part 2, Cohort 2 - Melanoma cohort: Patients with either histologically or cytologically confirmed advanced or recurrent melanoma who failed standard therapy (including a BRAF inhibitor for BRAF-mutant patients), are not eligible for standard therapy or for whom no effective standard therapy is available and have LDH < ULN.
- Presence of at least one tumor lesion that is laser ablation-accessible, with a minimum size of 1.0 cm and located (typically subcutaneously) that it can be treated with Ablation + IP-001 without risk of skin necrosis or serious damage to other adjacent vital and healthy tissue. This tumor lesion may either belong to the skin, lymph nodes, muscles or subcutaneous tissue.
Key exclusion criteria (12 listed)
- Malignant primary brain tumors, or clinically unstable symptoms from brain metastases or leptomeningeal disease, indicative of active disease.
- Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days (7 days for single fraction of palliative radiotherapy, 42 days for nitrosoureas or mitomycin C) prior to registration.
- Patients who have not recovered to ≤ CTCAE grade 1 from all side effects of prior therapies except for residual toxicities, such as alopecia, which do not pose an ongoing medical risk.
- Patients with a previously treated malignancy, when the risk of the prior malignancy interfering with either safety or efficacy endpoints is not very low.
- Patients with prostate cancer must have discontinued anti-androgens (e.g., bicalutamide, nilutamide) for at least 6 weeks prior to registration; chemical castration with luteinizing hormone-releasing hormone analogues must be continued or patients must be surgically castrated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IP-001Dose and route: Immediately (within 15 - 30 min) after thermal ablation, IP-001 will be injected in and around the ablated lesion. The amount of IP-001 injected depends on the dose level. | Drug | Ablation + IP-001 |
| Thermal AblationAlso: TRANBERG Thermal Therapy System®, Thermal Therapy System (Clinical Laserthermia Systems AB)The medical device includes a laser unit. The system continuously measures the temperature of the tissue, guiding the user to perform precise and safe treatments. Treatment time: 30 min | Device | Ablation + IP-001 |
Primary outcome
Part 1 and Part 2, cohort 1 (expansion cohort - STS): Dose-limiting toxicity (DLT)
Time frame: Day 1 to day 28
The primary endpoint is the frequency of DLTs which are relevant for the determination the tentative RP2D in Part 1 of the trial.
Part 2, Cohort 2 (phase IIa - melanoma): Disease control (DC) according to RECIST 1.1
Time frame: up to 12 weeks from treatment start
DC is defined as any complete response (CR), partial response (PR) or stable disease (SD) for 12 weeks from start of treatment according to RECIST 1.1 criteria achieved during trial treatment. Any patient with CR, PR or SD (≥ 12 weeks) as best observed response during trial treatment will be considered as a success; otherwise they will be considered as a failure. Patients without any response assessment during trial treatment will be regarded as having a non-evaluable response (NE) and thus will be considered as failures for this endpoint.
8 secondary outcomes
Objective response according to iRECIST (iOR)
Time frame: up to 12 weeks from treatment start
Disease control according to iRECIST (iDC)
Time frame: up to 12 weeks from treatment start
Duration of response according to iRECIST (iDoR)
Time frame: from date of response until date of disease progression according to iRECIST or death due to disease progression, whichever occurs first, assessed up to 4 years
Progression-free survival according to iRECIST (iPFS)
Time frame: from treatment start until date of disease progression according to iRECIST or death due to any reason, whichever occurs first, assessed up to 4 years
Objective response (OR) according to RECIST 1.1
Time frame: up to 24 weeks from treatment start
Disease control (DC) according to RECIST 1.1 (only for Part 2, Cohort 1)
Time frame: up to 24 weeks from treatment start
Duration of response (DoR) according to RECIST 1.1
Time frame: from date of response until date of disease progression according to RECIST 1.1 or death due to disease progression, whichever occurs first, assessed up to 4 years
Progression-free survival (PFS) according to RECIST 1.1
Time frame: from treatment start until date of disease progression according to RECIST 1.1 or death due to any reason, whichever occurs first, assessed up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
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Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Joerger, MD PhD study chair
Cantonal Hospital of St. Gallen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IP-001 and Thermal Ablation in people with Advanced Solid Tumors, run by Swiss Cancer Institute at 3 sites in Switzerland.
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 14 inclusion and 12 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Part 1 and Part 2, cohort 1 (expansion cohort - STS): Dose-limiting toxicity (DLT) (time frame: Day 1 to day 28). 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?
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 30 Dec 2025.