Study: NCT05325281

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CPI-613® (Dose level -1.0 250 mg/m^2)
Description: CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CPI-613® (Dose level -1.0 250 mg/m^2)
Description: CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CPI-613® (Dose level 1.0 500 mg/m^2)
Description: CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CPI-613® (Dose level 1.0 500 mg/m^2)
Description: CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CPI-613® (Dose level 2.0 1,000 mg/m^2)
Description: CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CPI-613® (Dose level 2.0 1,000 mg/m^2)
Description: CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CPI-613® (Dose level 3.0 1,500 mg/m^2)
Description: CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CPI-613® (Dose level 3.0 1,500 mg/m^2)
Description: CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CPI-613® Maximum Tolerated Dose (MTD)
Description: MTD will be determined by testing increasing doses of CPI-613®, starting from 500 mg/m\^2 and up to 1,500 mg/m\^2, on dose escalation cohorts of three patients (maximum 24 patients) in combination with Gem-RT therapy. MTD reflects the highest drug dose that does not cause unacceptable adverse effects, with a target dose-limiting toxicity (DLT) rate of 30%. Final dose will be revised as appropriate.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Subjects will be administered 400 mg/m\^2 gemcitabine once per week by IV infusion over approximately 30 minutes for six weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Subjects will be administered 400 mg/m\^2 gemcitabine once per week by IV infusion over approximately 30 minutes for six weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Subjects will be administered 400 mg/m\^2 gemcitabine once per week by IV infusion over approximately 30 minutes for six weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Subjects will be administered 400 mg/m\^2 gemcitabine once per week by IV infusion over approximately 30 minutes for six weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Subjects will be administered 400 mg/m\^2 gemcitabine once per week by IV infusion over approximately 30 minutes for six weeks.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Intensity-modulated Radiation Therapy
Description: 1.8 Gy per fraction, 5 fractions per week, 30 fractions total (54 Gy) across six weeks.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Intensity-modulated Radiation Therapy
Description: 1.8 Gy per fraction, 5 fractions per week, 30 fractions total (54 Gy) across six weeks.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Intensity-modulated Radiation Therapy
Description: 1.8 Gy per fraction, 5 fractions per week, 30 fractions total (54 Gy) across six weeks.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Intensity-modulated Radiation Therapy
Description: 1.8 Gy per fraction, 5 fractions per week, 30 fractions total (54 Gy) across six weeks.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Intensity-modulated Radiation Therapy
Description: 1.8 Gy per fraction, 5 fractions per week, 30 fractions total (54 Gy) across six weeks.