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LSTA1 Phase 2a basket trial in advanced solid tumors
EU CTIS ID: 2023-503740-14-00
What this study is testing
To evaluate the safety of LSTA1 in combination with SoC therapies compared to SoC therapies alone
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Subjects must be ≥ 18 years of age at time of consent and provide informed consent
- 8. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have primary tumor sites of the skin, paranasal sinuses, or the nasopharynx (any histology).
- 11. Inclusion Criteria First-line Cholangiocarcinoma - Pathologically confirmed metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma (GBC), with no prior systemic chemotherapy or targeted therapy or loco regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization). Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible a) Includes intrahepatic cholangiocarcinoma (IHC), extrahepatic cholangiocarcinoma (EHC), and gallbladder carcinoma (GBC), but not ampulla of Vater cancers b) For liver dominant IHC, disease must comprise < 60% of the liver parenchyma, as defined by computed tomography (CT) liver segmental volumetrics
- 12. If the patient has had decompression of the biliary tree within the last 14 days, stability of the bilirubin level needs to be confirmed with two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to randomization); both the first and second measurement must be ≤ 1.5 x ULN; stability is defined as the second measurement being no more than one point higher than the first
- 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- 3. Life expectancy ≥ 3 months, as determined by the investigator
You likely can't join if
- 1. Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to: • Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment • Active infection (viral, fungal, or bacterial) requiring systemic therapy • Known active HBV, HCV, or HIV infection • Active tuberculosis as defined per local guidance • History of allogeneic tissue/solid organ transplant • Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast • Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization; Pregnant or breastfeeding
- 26.Clinically significant ascites (palpable on exam, paracentesis in last 3 months preceding randomization, and/or symptomatic)
- 27.History of malignant bowel obstruction
- 10. Creatinine clearance < 45 mL/min (calculated using the Cockcroft-Gault formula below:) • Female CrCl = (140 - age in years) x weight in kg x 0.85 / 72 x serum creatinine in mg/dL • Male CrCl = (140 - age in years) x weight in kg x 1.00 / 72 x serum creatinine in mg/dL
- 28.Subjects with creatinine clearance < 60 mL/min (calculated using the Cockcroft-Gault formula below:) • Female CrCl = (140 - age in years) x weight in kg x 0.85 / 72 x serum creatinine in mg/dL • Male CrCl = (140 - age in years) x weight in kg x 1.00 / 72 x serum creatinine in mg/dL
- 3. Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
See the full eligibility criteria
Who can join
- 1. Subjects must be ≥ 18 years of age at time of consent and provide informed consent
- 8. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have primary tumor sites of the skin, paranasal sinuses, or the nasopharynx (any histology).
- 11. Inclusion Criteria First-line Cholangiocarcinoma - Pathologically confirmed metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma (GBC), with no prior systemic chemotherapy or targeted therapy or loco regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization). Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible a) Includes intrahepatic cholangiocarcinoma (IHC), extrahepatic cholangiocarcinoma (EHC), and gallbladder carcinoma (GBC), but not ampulla of Vater cancers b) For liver dominant IHC, disease must comprise < 60% of the liver parenchyma, as defined by computed tomography (CT) liver segmental volumetrics
- 12. If the patient has had decompression of the biliary tree within the last 14 days, stability of the bilirubin level needs to be confirmed with two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to randomization); both the first and second measurement must be ≤ 1.5 x ULN; stability is defined as the second measurement being no more than one point higher than the first
- 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- 3. Life expectancy ≥ 3 months, as determined by the investigator
- 4. At least one bidimensional measurable metastatic lesion assessed by RECIST 1.1. Tumor lesion located in the area of previous radiotherapy or other local and regional treatment sites is generally not a measurable lesion unless there is definite progression of the lesion, or the lesion persists three months after radiotherapy. Additionally, a biopsy site should not be considered a target lesion.
- 5. Adequate organ and marrow function: • Platelets ≥ 100 x 109/L (>100,000 per mm3) • WBC ≥ 3000/μL • Absolute neutrophil count ≥ 1.5 x 109/L • Serum albumin ≥ 2.5 g/L • ALT and AST ≤ 2.5 x ULN in the absence of liver metastases or < 5 x ULN in the presence of liver metastases • Bilirubin ≤ 1.5 x ULN • Hemoglobin ≥ 9.0 g/dL. Labs may be drawn 24 hours after a transfusion to meet this criterion. • INR < 1.5 (for patients not receiving therapeutic anticoagulation) • Adequate respiratory and cardiac function (PaO2 ≥ 60 mm Hg or oxygen saturation ≥ 92% on room air, and 12-lead ECG with normal tracing or non clinically significant changes that do not require medical intervention) • QT interval corrected using the Fridericia method (QTcF) < 470 ms
- 6. Adequate contraception: • All female patients will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically. Female patients of childbearing potential must agree to use two forms of highly effective contraception methods (a primary and a secondary method – see next bullet) during the study and for a period of 6 months following the last administration of the study drug, unless subject received cisplatin whereby aforementioned contraception methods must be adhered to for 14 months. • Male patients and their female partners, who are of childbearing potential and are not practicing total abstinence, must agree to use two forms of highly effective contraception methods (a primary and a secondary method) during the study and for a period of 6 months following the last administration of the study drug, unless subject received cisplatin whereby the following contraception methods must be adhered to for 14 months. These contraception methods include oral, transdermal, systemic or implant contraception birth control, intra-uterine devices (IUD), abstinence and double barrier method such as diaphragm with spermicidal gel or other recommended double barrier methods screening.
- 7. Inclusion Criteria Second-line Head and Neck Squamous Cell Carcinoma (HNSCC) - Patients with histologically confirmed recurrent or metastatic HNSCC that is unresectable or considered incurable by local therapies and that has progressed after first-line immunotherapy • Characterization of tumor PD-L1 expression using the PD-L1 IHC 22C3 PharmDx Assay • Receipt of prior treatment with checkpoint inhibitors as a single agent and have received at least 2 doses of the agent or a minimum of 6 weeks on treatment • Have documented clinical or radiographic progression by RECIST 1.1
What rules you out
- 1. Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to: • Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment • Active infection (viral, fungal, or bacterial) requiring systemic therapy • Known active HBV, HCV, or HIV infection • Active tuberculosis as defined per local guidance • History of allogeneic tissue/solid organ transplant • Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast • Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization; Pregnant or breastfeeding
- 26.Clinically significant ascites (palpable on exam, paracentesis in last 3 months preceding randomization, and/or symptomatic)
- 27.History of malignant bowel obstruction
- 10. Creatinine clearance < 45 mL/min (calculated using the Cockcroft-Gault formula below:) • Female CrCl = (140 - age in years) x weight in kg x 0.85 / 72 x serum creatinine in mg/dL • Male CrCl = (140 - age in years) x weight in kg x 1.00 / 72 x serum creatinine in mg/dL
- 28.Subjects with creatinine clearance < 60 mL/min (calculated using the Cockcroft-Gault formula below:) • Female CrCl = (140 - age in years) x weight in kg x 0.85 / 72 x serum creatinine in mg/dL • Male CrCl = (140 - age in years) x weight in kg x 1.00 / 72 x serum creatinine in mg/dL
- 3. Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
- 4. Have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, and other anti-tumor therapy within 28 days prior to randomization
- 5. History or clinical evidence of CNS metastases; exceptions include: • Subjects who have completed local therapy and who meet both of the following criteria: − Subjects must be asymptomatic AND − Subjects must have no requirement for steroids 6 weeks prior to start of study treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS Metastases
- UPD 6. Exclusion Criteria Second-line Head and Neck Squamous Cell Carcinoma (HNSCC) - Patients who received prior taxanes unless it was given as part of neoadjuvant, concurrent therapy in the curative intent setting and it has been more than 6 months since last dose
- 7. Known allergies to taxanes or their standard pretreatments
- 8. Any surgery involving the HNSCC for which the patient is being treated (except biopsies) that occurred within 28 days prior to randomization
- 19. Concurrent use of immunosuppressive medication, EXCEPT for the following: a. Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- UPD 9. Subjects who cannot discontinue any concomitant medications that are inducers or inhibitors of CYP2C8 (e.g., rifampicin, phenobarbital, secobarbital, phenytoin, clopidogrel, gemfibrozil, zafirlukast, felodipine) ) or CYP3A4 (e.g., dexamethasone, carbamazepine, phenytoin, phenobarbital, rifampin/rifampicin, rifabutin, St. John’s Wort, erythromycin, itraconazole, ritonavir, verapamil) during treatment with paclitaxel
- 16. Exclusion Criteria First-line Cholangiocarcinoma - Patients who received prior palliative systemic treatment for their advanced cancer
- 17. Patients with a history of idiopathic pulmonary fibrosis (pneumonitis requiring treatment with steroids), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on baseline imaging
- 18. Patients with a history of active interstitial lung disease
- 2. Subjects with a known sensitivity to LSTA1 or its excipients
- 20. Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent. Patients with Type 1 diabetes, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis)
- 21.Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab. Note: While enrolled, patients should not receive any live vaccines while receiving durvalumab and up to 30 days after last dose of durvalumab.
- 22.Patients who experience any grade 3-4 gastrointestinal (GI) bleeding within 3 months preceding randomization
- 23.Diagnosis of sclerosing cholangitis
- 24.Diagnosis of hepatic encephalopathy
- 25.Current biliary obstruction requiring surgical diversion or placement of endoscopic or transhepatic stents for biliary decompression
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.